Press Releases

It was a snowy week in February 2009 when David Whitlock packed up his three-bedroom apartment near Cambridge, Mass., and moved into his van. Then 54 years old, the inventor had spent all his money, almost half a million dollars, on worldwide patent filings for a newfound obsession: a type of bacteria, culled from soil samples, that he theorized would improve skin disorders, hypertension, and other health problems. “It was the most important thing I could work on,” Whitlock says. “But I knew I needed patents, otherwise I wouldn’t be able to get anyone interested.”

To make his white Dodge Grand Caravan habitable, Whitlock sawed down his queen-size bed frame and squeezed it in. He donated or abandoned most of his furniture, storing his lab equipment in a barn owned by his business partner, Walter “Hilly” Thompson. Then Whitlock drove to his former employer, cement company Titan America LLC, where he still had an office and did some consulting. Without asking permission, he pulled into the parking lot and made it home for the next four and a half years. “I found that if I stayed fully dressed and got inside two sleeping bags, I could tolerate it,” he says of the coldest winter nights.

Every so often, he would coat himself in a concoction made with his homegrown bacteria, a ritual he’d begun years earlier in the belief it would improve his overall health and all but eliminate the need to bathe or use soap. Then he’d spend the day in his office, tirelessly researching microbes. “A lot of people gave me shit for living in my car,” Whitlock says. “But it was like nothing, trivial.” His real problem was finding investors, a challenge exacerbated by his autism spectrum disorder. To get his message out, he relied mainly on Thompson. Most everyone dismissed the duo’s idea as nuts.

Today things look very different. Whitlock lives in an apartment, and his startup, AOBiome Therapeutics Inc., has raised almost $100 million. The company is seeking to become the first to get Food and Drug Administration approval for pharmaceutical-grade topical live bacteria, with six clinical trials under way to treat acne, eczema, rosacea, hay fever, hypertension, and migraines.

Read Full Article

Data from its First Pediatric Study are Anticipated in the Second Half of 2019

CAMBRIDGE, Mass., March 6, 2019 /PRNewswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage microbiome company focusing on the research and development of therapeutics for dermatological conditions, migraine, hypertension and other systemic diseases, today announced the administering of its lead product candidate, B244, to the first patient in the Company’s Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema).

The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria (“AOB”), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period.

“There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population,” said President & CEO, Todd Krueger. “We look forward to announcing results from this study in the second half of 2019.”

In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema.¹ Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.²

“Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB’s nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment,” said Chief Medical Officer, Dr. Judith Ng Cashin, M.D. “Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244’s innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients.”

In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019.

Additional information regarding this and AOBiome’s other ongoing clinical programs may be found at www.clinicaltrials.gov.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics, Inc.
AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes multiple clinical-stage programs: a completed Phase 2 study to treat patients with acne vulgaris or acne, a Phase 1b study to treat patients with pediatric eczema (atopic dermatitis), a Phase 2 study to treat patients with adult eczema (atopic dermatitis), a Phase 2 study for the prevention of episodic migraines, and a Phase 1b/2a clinical trial for the treatment of allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Ryo Imai
212-213-0006, ext. 315
rimai@burnsmc.com

AOBiome Advancing Six Clinical Phase Programs, including Three Trials Testing Its Lead Asset for the Topical Treatment of Eczema, Acne, and Rosacea

CAMBRIDGE, Mass., Jan. 2, 2018 /PRNewswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage microbiome company focusing on the research and development of a novel class of drugs for inflammatory conditions, central nervous system disorders, and other systemic diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the use of the Company’s Ammonia Oxidizing Bacteria (AOB) for the treatment eczema. U.S. Patent No. 10,017,731 is directed to the use of AOB for the treatment of a wide spectrum of symptoms in individuals with eczema.  AOBiome is currently conducting a Phase 2 clinical trial investigating AOB for the treatment of eczema with expected readout in 2019.  In addition to its eczema trial, AOBiome is pursuing four additional indications in Phase 2, including acne where a Phase 2 study has recently concluded and the Phase 3 studies are planned to begin within the first half of 2019.

Atopic dermatitis or eczema is a recurring inflammatory skin disease which poses a significant burden on patients’ quality of life. The disease can present with a broad spectrum and combination of symptoms, including skin redness, dryness, flakiness, and chronic itching.  According to the US Centers for Disease Control and Prevention (CDC), the average prevalence rate of eczema in US children ages 0-17 is 11% and it can be as high as 20% in certain demographic groups.  Amongst adults, several research studies have reported a US prevalence rate of approximately 7% of the total adult population. In addition to the significant disease and quality of life burden for patient’s suffering from eczema, there is also a significant economic burden, which one recent study estimated at over $5B USD annually.

“AOBiome has continued to significantly broaden its portfolio of patents and patent applications covering diverse applications of our AOB technology in diseases with compelling unmet needs,” said Todd Krueger, President and Chief Executive Officer of AOBiome. “We are pleased with the progress of our lead AOB programs, including multiple clinical trials focused specifically on inflammatory skin conditions, and we anticipate reporting additional clinical findings from one or more of these studies in 2019.”

“Up to 20% of Americans suffer from atopic dermatitis, often starting in childhood or adolescence.   Half of those children continue to have symptoms in adulthood, including chronic itch.  Current therapies include potent steroids and immunomodulators and these therapies, even if they offer relief have significant side effects,” said Dr. Jun Wang, CEO of iCarbonX and former CEO of Beijing Genomic Institute (BGI), Chairman of the Board of Directors of AOBiome. “Through the application of ammonia oxidizing bacteria, we hope to provide better relief from the redness and the itch by rebalancing the skin microbiome in a manner where the patient experiences minimal to no side effects.”

AOBiome has six ongoing clinical programs in acne, eczema, rosacea, allergic rhinitis, migraine, and hypertension, along with multiple ongoing preclinical programs, including ones addressing pulmonary and gastrointestinal disorders. AOBiome has identified significant therapeutic opportunities by using its proprietary topical and intranasal formulations incorporating a live single strain of Nitrosomonas eutropha in different potencies and formulations tailored to each of its clinical trials. For reference, please visit the company’s website here. The company is also seeking to expand its proprietary development approach to explore and develop additional microbiome programs.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics, Inc.
AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes six clinical-stage programs: a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial in hypertension, a Phase 2 study to treat patients with eczema (atopic dermatitis), a Phase 2 study for the prevention of episodic migraines, a Phase 2 study to treat rosacea, and a Phase 1b/2a clinical trial for the treatment of allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Ryo Imai
212-213-0006, ext. 315
rimai@burnsmc.com

CAMBRIDGE, Mass., Dec. 18, 2018 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a leading clinical-stage microbiome company focusing on the research and development of a novel class of drugs for inflammatory conditions, central nervous system disorders, and other systemic diseases, today announced that Dr. Judith Ng Cashin, M.D., has joined the company as Chief Medical Officer effective as of October 1, 2018.

"Dr. Ng Cashin has extensive background in both infectious disease and dermatology and will be invaluable as we advance microbial-based drugs through clinical development," said AOBiome's President and CEO Todd Krueger. "She brings a wealth of experience to the team in both early and late stage drug development with major pharmaceutical companies where she managed clinical research, interacted with the FDA, and developed clinical and portfolio strategies. We look forward to the insight and depth of knowledge Judi brings to AOBiome."

Most recently, Dr. Ng Cashin served as Chief Scientific Officer at Syneos Health, a pharmaceutical services provider created by the merger of INC Research and inVentiv Health, where she led the integration of the therapeutic, medical, and scientific operations within product development and Phase 1-4 trial delivery. Prior to Syneos, Dr. Ng Cashin served as the Vice President of Medical Strategy and then of Advisory Services for IQVIA, formerly Quintiles, a management consultancy focused on biopharma and the healthcare industry. Her experience also includes nine years with GlaxoSmithKline (GSK) in senior medical leadership roles including, Vice President of Medical Excellence and Quality, Vice President and Global Head, Infectious Diseases Medicines Development Center, as well as Vice President of Stiefel Laboratories, GSK's dermatology franchise focusing on acne treatments and anti-infectives.

Dr. Ng Cashin is currently a board member of the Drug Information Association (DIA). She earned her M.D. from Rush Medical College and trained in Internal Medicine at the University of Chicago. She subsequently undertook her sub-specialty fellowship training at the University of North Carolina at Chapel Hill in infectious diseases and hematology/oncology after which she served on the clinical faculty.

"Joining the AOBiome team is an exciting opportunity to advance the application of ammonia oxidizing bacteria to the treatment of human disease. Reestablishing the symbiotic relationship between bacteria and human to restore important biologic and biochemical processes is a growing area in science and medicine. At AOBiome, we have the potential to bring a first-in-class live biotherapeutic to patients. With my experience in microbiology, infectious diseases, dermatology, and drug development, I believe I can help lead the company toward this goal," said Dr. Ng Cashin.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics, Inc.
AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes six clinical-stage programs: a Phase 2b study to treat patients with acne vulgaris or acne, a Phase 2 trial in hypertension, a Phase 2 study to treat patients with eczema (atopic dermatitis), a Phase 2 study to treat migraines, a Phase 2 study to treat rosacea, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.

Contacts:
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Source: AOBiome Therapeutics

New appointments integrate broad expertise in clinical development, medicine, finance and business management.

CAMBRIDGE, Mass., Aug. 6, 2018 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases, today announced the expansion of its Board of Directors with the appointments of (i) Professor Klaus Dugi, Executive Vice President and Chief Medical Officer of Ferring Pharmaceuticals, (ii) Dr. Anna Lisa Jenkins, MBBS, FRCP, Chief Executive Officer of PlaqueTec Ltd. and (iii) Mr. Doug Rosefsky, partner of Prudentia Capital S.A.S., as independent non-executive directors. Mr. Rosefsky will lead the audit committee and Dr. Jenkins will lead the remuneration committee.

"We are very excited to announce the additions of Klaus, Anna Lisa and Doug to the AOBiome Board of Directors," said Mr. Todd Krueger, President and Chief Executive Officer of AOBiome. "These industry veterans bring to AOBiome a broad range of expertise in clinical development, medicine, finance and business management experience. We look forward to benefiting from their strategic insights that will be invaluable to the future direction of the Company."

"It is an honor to bring these seasoned veterans to AOBiome at this important time in the Company's expansion," said Dr. Jun Wang, Chairman of the Board of Directors of AOBiome. "With the company rapidly accelerating its innovative Ammonia Oxidizing Bacteria platform across multiple applications, we are that much closer to achieving our long-term goals within the microbiome space."

Professor Klaus Dugi

Dr. Dugi has over 25 years of experience mainly in the field of medicine. Since 2017, Dr. Dugi has served as Executive Vice President and Chief Medical Officer of Ferring Pharmaceuticals, a multinational pharmaceutical company, and continues to serve in these capacities. His responsibilities at Ferring Pharmaceuticals include medical affairs, pharmacovigilance and quality assurance. In addition, he served at Boehringer Ingelheim, a pharmaceutical company, as Country Managing Director of UK and Ireland from 2015 to 2017, as Chief Medical Officer from 2010 to 2015, as Corporate Vice President of Medical Affairs from 2008 to 2009, and as Vice President of Therapeutic Area Metabolic Diseases from 2006 to 2008. His responsibilities at Boehringer Ingelheim included translational medicine and clinical pharmacology, medical affairs and clinical operations. From 2001 to 2002, Dr. Dugi was the attending physician at the medical clinic of Heidelberg University. He conducted basic and applied biomedical research in the field of atherosclerosis, diabetes and lipid metabolism at the National Institutes of Health in Bethesda, Maryland between 1991 and 1996. He is qualified as a professor of medicine at Heidelberg University, Germany, and he teaches internal medicine and endocrinology at the university.

Anna Lisa Jenkins, MBBS, FCRP

Dr. Jenkins, MBBS, FRCP is currently the Chief Executive Officer of PlaqueTec. Prior to joining PlaqueTec, she was Chief Executive Officer of Dimension Therapeutics, a gene therapy company, until Dimension was acquired by Ultragenyx Pharmaceuticals, a biopharmaceutical company, in 2017. From 2011 to 2014, Dr. Jenkins served at Merck Serono, a German pharmaceutical company, first as its Executive Vice President Global Development and Medical, and then as its Head of Global Research and Development. Prior to this, Dr. Jenkins held several roles at Bristol Myers-Squibb, a global biopharmaceutical company, from 1997 to 2011, including as it Senior Vice President and Head of Global Medical Affairs. Earlier in her career, Dr. Jenkins was a medical officer in the British Royal Navy, achieving the rank of surgeon lieutenant commander.

Doug Rosefsky

Mr. Rosefsky has nearly 25 years of experience mainly in the field of finance, accounting and c-level management. Since July 2017, Mr. Rosefsky has been a partner of Prudentia Capital S.A.S., a private equity fund management company based in France, where he is responsible for investment advisory services. From 1999 to 2015, Mr. Rosefsky was a managing director and European executive committee member of Alvarez & Marsal. From 2010 to 2011, he was an advisor to the board of directors of European Gas Limited, S.A., an oil and gas company listed on the Australian Stock Exchange (stock symbol EPG), which was later renamed as Fitzroy River Corporation Limited (stock symbol FZR). From 2005 to 2007, he served as the Chief Financial Officer and subsequently the Chief Executive Officer at North Atlantic Trading Company and North Atlantic Holding Company, both of which were publicly reported companies and are subsidiaries of Turning Point Brands, Inc., which is listed on the New York Stock Exchange (stock symbol TPB).

About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform includes patented, proprietary, topical and intranasal formulations which incorporate a single strain of AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB consume ammonia and produce nitrite and nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics
AOBiome Therapeutics is a Cambridge, Massachusetts based life sciences company focused on transforming human health by developing microbiome-based therapies for local, intranasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT trained chemical engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes six clinical-stage programs in the following indications; acne vulgaris, hypertension, eczema (atopic dermatitis), migraine, rosacea, and allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.

Contacts:
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Source: AOBiome Therapeutics

AOBiome Advancing Six Programs in Clinical Testing Based on Ammonia Oxidizing Bacteria (AOB) Platform Expertise

CAMBRIDGE, Mass., June 4, 2018 -- AOBiome Therapeutics ("AOBiome"), a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases, today announced the election of Jun Wang, Ph.D., founder and CEO of iCarbonX, as Chairman of AOBiome's Board of Directors, effective May 31, 2018. Dr. Wang has served on the Board of Directors since 2016.

"On behalf of the AOBiome Board of Directors and its leadership team, we enthusiastically welcome Jun to his new role as the company's Chairman. Throughout his Board tenure, Jun's expertise and clear vision was of great value to us in formulating and overseeing the overall development strategies and business plans of the company, which led to a successful diversification of our development pipeline," said Todd Krueger, President and Chief Executive Officer of AOBiome.

AOBiome is currently advancing six clinical trials of proprietary, topical and intranasal formulations incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The company is also seeking to expand its proprietary development approach to explore and develop additional microbiome programs.

Dr. Jun Wang is the founder and CEO of iCarbonX, a company leading the post-genomic era by creating a platform for digitizing, analyzing, and understanding life. Prior to founding iCarbonX in 2015, Dr. Wang was the CEO and co-founder of BGI (previously known as the Beijing Genomics Institute), one of the world's premier research facilities committed to excellence in genome sciences. During his tenure at BGI, Dr. Wang managed three rounds of fundraising totaling approximately $1 billion, and acquired the U.S.-based public company Complete Genomics. He has authored more than 300 peer-reviewed articles and has been recognized with numerous awards and citations. In addition to his role at iCarbonX, Dr. Wang serves as Ole Rømer Professor at the University of Copenhagen. He received a B.S. in artificial intelligence and a Ph.D. in bioinformatics from Peking University.

"The early successes of our clinical programs have set course for our rapid expansion," stated James Heywood, AOBiome Founder and Board Member. "Pairing Jun's vision with Todd's tactical expertise, AOBiome will continue to seize this moment and significantly accelerate our clinical programs to prove the full value of AOB to human health, and further diversify our pipeline."

"I am honored to serve as the Chairman of AOBiome's Board of Directors at this important time for the company," said Dr. Wang. "Microbiome-based therapies are accelerating at a very fast pace with many new potential applications. AOBiome has propelled its programs forward, leading and innovating unique approaches with its AOB, including industry-first intranasal administration in multiple applications. I look forward to the continued progress of the company."

About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About AOBiome Therapeutics
AOBiome Therapeutics is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes six clinical-stage programs: A Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, a Phase 2 study to treat patients with atopic dermatitis, a Phase 2 study to treat episodic migraines, a Phase 2 study to study rosacea, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com. 

Contacts:
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Source: AOBiome Therapeutics

Patient Dosing Has Begun in First-in-Class Nitric Oxide Modulating, Microbiome-based Therapy 

Cambridge, MA, April 23, 2018 

AOBiome Therapeutics ("AOBiome"), a clinical-stage life sciences company advancing patented microbiome-based therapies, today announced that AOBiome has expanded its clinical-stage pipeline with the initiation of a randomized, double-blind, Phase 2 study to assess safety, tolerability, and efficacy of its first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate as a preventive treatment in episodic migraine. The Company’s AOB will be administered as an intranasal spray, the first application of this delivery approach in a clinical trial for a microbiome-based migraine therapy. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation, and to nitrite, altered levels of which are associated with migraines.

"Initiation of our migraine study extends our AOB pipeline to a broad neurology indication for the first time. The trial also further builds on our capabilities in intranasal delivery, which has recently shown promising safety data in treating individuals with seasonal allergic rhinitis," said Todd Krueger, President and Chief Executive Officer of AOBiome.

“Migraine is the third most common illness in the world and is considered one of the top six most disabling illnesses,” said David Kudrow, M.D., director of the California Medical Clinic for Headache, Santa Monica, California. “Options for migraine prevention are currently limited and often demonstrate inadequate efficacy or side effects limiting their usefulness. More than 50% of patients that start preventive medications stop taking them within 6 months either because they are not effective or not well-tolerated. There is a substantial need for new, effective migraine preventive therapies with acceptable safety profiles. I look forward to the progress of AOBiome’s clinical development program for migraine prevention.”

About the Phase 2 Episodic Migraine Trial 
AOBiome’s prospective, randomized, vehicle-controlled, double-blind, Phase 2 study will assess safety, tolerability, and efficacy of the Company’s first-in-class AOB product candidate delivered as an intranasal spray for preventive treatment in 303 subjects with episodic migraine. Patients will be randomized 1:1:1 in three arms (lower dose AOB, higher dose AOB, and vehicle). Safety constitutes the primary clinical endpoint, with secondary endpoints measuring mean change and reductions in migraine days and attacks. Additional information about AOBiome’s Phase 1b/2a study in seasonal allergic rhinitis (SAR) may be found at ClinicalTrials.gov identifier: NCT03488563.

About Ammonia Oxidizing Bacteria (AOB) 
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. 

About Migraine 
Migraine is a chronic, recurrent disorder affecting an estimated 37 million Americans. Around 12% of adults have episodic migraine (headaches on less than 15 days per month). The treatment of migraine often consists of acute/abortive therapies, which, while effective in many cases, may be limited by side effects, the potential for medication overuse/rebound, and some contraindications. Preventive therapies are also used, but current approaches are not disease-specific and are often marked by tolerance issues, such that adherence to therapy is typically low. Nearly half of individuals with episodic or chronic migraine who are in need of preventive therapies do not receive them.

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes five clinical-stage programs: a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, a Phase 2 study to treat patients with atopic dermatitis, a Phase 2 study to treat episodic migraines, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.  

Contacts: 
For Media Inquiries: 
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

Nitric Oxide Modulating Product Candidate Demonstrates Promising Safety and Tolerability in Phase 1b/2a Study

Intranasal Delivery Applicable to Diverse Indications, including Seasonal Allergic Rhinitis (SAR)

AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies, today announced clinical findings from Part 1 of a Phase 1b/2a clinical trial of the Company’s first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation. In Part 1 of the double-blind, multi-dose, vehicle-controlled Phase 1b/2a trial, AOBiome’s candidate demonstrated promising safety and tolerability when delivered intranasally to healthy volunteers (N=24, randomized 1:1:1 high dose AOB, low dose, and vehicle) over a period of two weeks:

• All adverse events were mild in severity, none of which were considered to be related to the study drug. Additionally, there were no serious adverse events and no discontinuations.
• There were no infectious or inflammatory complications nor local/systemic adverse events related to study drug and no changes in nasal patency, anatomy, or architecture.

Based on these promising results, AOBiome announced that it has initiated Part 2 of its Phase 1b/2a trial to assess preliminary efficacy in subjects with seasonal allergic rhinitis (SAR).

“We are thrilled to announce these latest clinical results, which further underscore the consistently compelling safety findings for our AOB candidate across modalities, including topical and now intranasal delivery,” said Todd Krueger, President and Chief Executive Officer of AOBiome. “We believe our intranasal approach has a number of potential applications beyond rhinitis, including migraines.”

Mr. Krueger continued, “Achievement of this milestone also signals AOBiome’s leadership in translating its novel microbiome-related science into rigorous clinical programs with relevance to human health and disease. We believe we are at the forefront of this rapidly evolving field, and we will continue to drive earlier-stage discoveries across multiple platforms, applying our expertise in systems chemistry and next-generation sequencing technologies to understanding the role and therapeutic benefits of the human microbiome.”

About the Phase 1b/2a Trial
AOBiome’s Phase 1b/2a clinical trial of their AOB product candidate is a randomized, multi-dose, double-blind, vehicle-controlled study designed to evaluate safety and tolerability in up to 24 healthy volunteers and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen. Additional information about AOBiome’s Phase 1b/2a study in SAR may be found at ClinicalTrials.gov, using Identifier NCT: NCT03290248.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Seasonal Allergic Rhinitis
Seasonal allergic rhinitis (SAR) is an inflammatory disease in which exposure to outdoor allergens, such as plant pollen or mold spores, results in inflammation of the nasal passages. Individuals with allergic rhinitis may experience symptoms including sneezing, runny nose, nasal itch, and nasal congestion, which can have a significant impact on patients depending on the degree of severity. According to the Centers for Disease Control and Prevention, SAR affects nearly 8% of the U.S. population (see reference for 2015 statistics). Unmet needs in SAR are substantial, particularly in regard to achieving a balance between potential side effects and adequate symptom control.

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes three clinical-stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts
For Media Inquiries:
Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

AOBiome Therapeutics (“AOBiome”) today announced that Todd Krueger has been named Chief Executive Officer, effective immediately. Mr. Krueger retains his current role as President, a position he has held since March 2016. AOBiome is a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions.

“We are very pleased to have Todd take on the role of CEO at this pivotal time for AOBiome,” said AOBiome’s Chairman and Co-Founder Jamie Heywood. “The company is advancing multiple mid-clinical stage programs based on its first-in-class Ammonia Oxidizing Bacteria (AOB) platform, which we expect will have key data readouts over the course of the next year and into 2019. Todd’s exemplary track record and his unique expertise across healthcare strategy, business development, and operations will be essential in guiding the company through its next stage of development.”

Mr. Krueger joined AOBiome in May 2015 as Chief Business Officer, prior to which he served as Head of Commercial Strategy and Operations for the Genomics Platform at the Broad Institute. Previously, Mr. Krueger held senior positions at Life Technologies, including Head of Business Development for Genetic Systems and Head of Business Development for Molecular Medicine, focused on the company’s companion diagnostics business. He has also been involved in the founding of several biotechnology companies, including Gynesonics, Nodality, and Anestis Therapeutics. In 1999, he co-founded Fluidigm Corporation, a publicly traded life sciences technologies and tools company, where he served as CFO and Vice President of Business Development. Mr. Krueger is a member of the Board of Directors for multiple companies, including General Automation Lab Technologies (GALT), a microbiome tools company. He started his career as a consultant for Bain and Company in Boston. Mr. Krueger graduated Highest Distinction from Northwestern University with a degree in Economics and earned his MBA from the Kellogg School of Management.

“It has been a privilege to work closely with the accomplished team at AOBiome as we have advanced and expanded our development pipeline targeting diverse inflammatory conditions,” said Todd Krueger, President of AOBiome. “In 2018 and beyond we will continue to focus on developing innovative clinical programs and applying our world-class scientific platform to address areas of compelling unmet patient needs.”

About AOBiome

AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by PatientsLikeMe founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes three clinical-stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:
For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com

First-in-Class Therapy Demonstrates Statistically Significant 2-Point Reduction (p=0.03) in Investigator’s Global Assessment (IGA) 

AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced positive efficacy and safety findings from the Phase 2b clinical trial of the Company’s Ammonia Oxidizing Bacteria (AOB) product candidate for the treatment of mild-to-moderate acne vulgaris. AOBiome’s candidate is a first-in-class, topical formulation of a single strain of beneficial AOB, Nitrosomonas eutropha. The Phase 2b study achieved the primary endpoint at week 12 of a statistically significant 2-point reduction in an Investigator’s Global Assessment (IGA) of acne severity compared to vehicle control (p=0.03). The study also showed a trend in the reduction of the number of inflammatory lesions compared to control, a second primary endpoint; this difference reached statistical significance in the per protocol treatment group (p=0.028, log transformation analysis). AOBiome’s candidate was well-tolerated, demonstrating no treatment-emergent adverse events.

“We are proud of the continued success and progress of our acne program. This, coupled with the recently announced initiation of our Phase 1b/2a clinical trial for allergic rhinitis, highlights the versatility and broad utility of our anti-inflammatory platform.” said Todd Krueger, President of AOBiome. “Application of our AOB to more than 270 individuals across disease areas with virtually no side effects underscores the potential of our platform to address inflammation contributing to a broad range of diseases, supporting our continued leadership in the development of innovative therapeutics.”

AOBiome’s randomized, double-blind, placebo-controlled Phase 2b study evaluated AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study were designed to assess safety and efficacy as demonstrated by an Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study was jointly conducted with Science 37, a clinical research company, that has pioneered a “site-less” clinical trial model with its proprietary mobile technology, the Network Oriented Research Assistant (NORA®) used in the trial to capture real-time data from patients at their homes. The Principal Investigator of the study was Noah Craft MD, PhD, a dermatologist, microbiologist, and CEO of Science 37, Inc. A previous Phase 1b/2a dose-ranging safety study resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. Additional information about AOBiome’s Phase 2b study in acne may be found at ClinicalTrials.gov, using Identifier NCT: NCT02832063.

“We are very excited by these positive findings, which to our knowledge are the first to demonstrate that a single strain of beneficial AOB can have a clinically meaningful impact on acne, a known challenge with current available therapies,” stated Chief Medical Officer, Larry Weiss, MD. “In addition, safety and side effects are important challenges with marketed products and our ability to reduce disease severity with no treatment-related safety events offers a potentially differentiated profile to available interventions.”

Given the positive results of the Phase 2b study in acne, AOBiome plans to expand its dermatology platform to include atopic dermatitis, pruritus, and rosacea.

About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB normally found on the body. Once deployed, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Acne
Acne affects approximately 40 to 50 million people in the U.S., where it is the most common skin condition and the top reported cause for dermatologist visitations, accounting for about one-fourth of U.S. dermatologists’ patient volume. U.S. sales of the Top 10 branded acne therapeutics have a $3 billion run rate. However, despite the significant spend on prescription and over the counter remedies, acne remains an area of significant unmet medical need as treatments are either marginally effective (topical antibiotics, topical retinoids, astringents) and/or associated with serious risks (oral retinoids).

About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical stage therapeutic candidates. The company’s portfolio includes three clinical stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com