Press Releases

First-in-Class Therapy Enables Intranasal Delivery of Nitric Oxide 

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced the initiation of patient enrollment in AOBiome’s Phase 1b/2a clinical trial of the Company’s Ammonia Oxidizing Bacteria (AOB) product candidate, for the treatment of seasonal allergic rhinitis (SAR). The initiation of enrollment represents a first-in-class, intranasal formulation incorporating a single strain of beneficial ammonia-oxidizing bacteria (AOB), Nitrosomonas eutropha. Once administered, the AOB convert naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation.

“AOBiome continues its leadership in innovation with the initiation of what we believe is the first FDA-supported clinical study to test intranasal application of a microbiome-targeted therapy,” said Todd Krueger, President of AOBiome. “The SAR trial is designed to provide early evidence for the potential efficacy of our approach as a prophylactic treatment for those who suffer from seasonal allergies. In addition, we look forward to establishing safety and tolerability with another route of delivery, which will allow us to pursue a broader range of diseases that are amenable to intranasal delivery.” To date, AOBiome’s AOB formulations have been tested in more than 270 individuals, with no serious adverse events and no difference in adverse events between treatment and vehicle groups.

AOBiome’s Phase 1b/2a clinical trial of their AOB product candidate is a randomized, 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.

“Current treatments for SAR are frequently associated with local and/or systemic adverse effects that can cause many patients to pursue alternative strategies for control of their symptoms,” stated Chief Medical Officer, Larry Weiss, MD. “Our platform seeks to address SAR through a novel approach, adjusting human commensal bacteria in the nasal microbiome to rebalance inflammatory processes underlying disease. We look forward to sharing the progress of our clinical program utilizing intranasal delivery.”

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 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 AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local 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 novel therapeutic candidates for systemic, nasal, and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is advancing 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 to Locally Deliver Nitric Oxide.

Ongoing Phase 2b Study with Lead Candidate in Individuals with Mild-to-Moderate Acne Vulgaris 

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the Company’s Ammonia Oxidizing Bacteria (AOB) for the treatment of acne. The lead candidate is currently in development for multiple indications, including an ongoing Phase 2b study for acne vulgaris, and multiple earlier-stage clinical studies for allergic rhinitis and other inflammatory conditions. U.S. Patent No. 9,738,870 is directed to methods of use for AOB for the treatment of inflammatory or non-inflammatory lesions in individuals with acne vulgaris. “AOBiome is continuing to build a broad portfolio of patents and patent applications encompassing composition and methods of preparation and use across diverse therapeutic applications with compelling unmet needs,” said Todd Krueger, President of AOBiome. “We are pleased with the progress of our lead program with AOB in our ongoing Phase 2b clinical trial, which recently completed the last patient visits for individuals with mild-to-moderate acne vulgaris. We expect this study will provide important information regarding the potential of our promising therapeutic agent to treat acne while avoiding both local and systemic adverse effects that are often associated with current standard of care.” About Ammonia Oxidizing Bacteria (AOB)

AOBiome’s AOB platform is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. The platform is designed to repopulate the skin microbiome with AOB normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, 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. The Company’s multicenter, randomized, double-blind, placebo-controlled Phase 2b study is evaluating AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study are designed to assess safety and efficacy as demonstrated by Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study is being jointly conducted with Science 37, a clinical research organization. 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. 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

AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local 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 novel therapeutic candidates for systemic and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is progressing clinical trials in allergic rhinitis and 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 Designed to Deliver Nitric Oxide for Application in Diverse Inflammatory Conditions

AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, announced today completion of patient enrollment in the Company’s Phase 2 clinical trial of its lead product candidate, designated B244, to treat individuals with elevated blood pressure. The multicenter, randomized, double-blind, vehicle-controlled Phase 2 study is evaluating B244, a first-in-class, topical formulation of beneficial ammonia-oxidizing bacteria (AOB), in up to 116 individuals with either systolic prehypertension or systolic Stage 1 hypertension. Primary outcome measures of the Phase 2 study will address safety and provide an initial efficacy readout comparing mean reductions in systolic blood pressure in active and vehicle control groups in the 4-week treatment period.

“We are pleased with the rapid advancement of our Phase 2 program, which featured an effective patient recruitment campaign conveying the advantages of topical therapeutic application,” said Todd Krueger, President of AOBiome. “The principal goal of the Phase 2 trial will be to confirm previous clinical findings, including positive safety results and data demonstrating the potential to lower blood pressure in human subjects. Based on our progress, we anticipate completing the trial in the second half of this year.”

A previously conducted Phase 1b/2a acne study of B244 reported no serious adverse events and no difference in adverse events between treatment and vehicle groups among patients with acne vulgaris, an indication currently being tested in an ongoing Phase 2b study. Results from the Phase 1b/2a acne trial also showed dose-dependent reductions in blood pressure in normotensive subjects, achieving statistically significant decreases compared to placebo in patients receiving the highest treatment dose.

AOBiome’s B244 is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. B244 is designed to repopulate the skin microbiome with AOBs normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, B244 converts ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

“The ability to reliably and effectively deliver nitric oxide may benefit individuals with elevated blood pressure, including prehypertensive patients and those with Stage 1 hypertension, many of whom wish to avoid the adverse effects associated with currently approved blood pressure medications,” stated Chief Medical Officer, Larry Weiss, MD. “Pending further confirmation in clinical studies, the promising safety data and blood pressure lowering activity of B244 have the potential to profoundly affect the quality of life of patients, and I look forward to the continued progress of the program.”

About AOBiome
AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local 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 novel therapeutic candidates for systemic and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is progressing clinical trials in allergic rhinitis and eczema and earlier-stage preclinical programs targeting diverse indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries:

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

Improving the Appearance of Keratosis Pilaris with Ammonia Oxidizing Bacteria

Presented at the Late-breaking Forums during the 2017 Annual Meeting in Orlando, FL, March 3-7, 2017 by:

Dr. Nicole Lee, MD, MPH

Saturday, March 4 from 10:50 AM – 11:00 AM

AUTHORS: Nicole Y Lee¹, MD, MPH, Shilpi Khetarpal¹, MD, Kathleen G Petrell¹, Mariya Gaber², Spiros Jamas², ScD, Ioannis Gryllos², PhD, D. Davidson Easson Jr², ScD, Jeffrey S Dover¹, MD, FRCPC

¹ SkinCare Physicians, Chestnut Hill, MA
2AOBiome, LLC, Cambridge, MA

ABSTRACT

Keratosis pilaris is a common skin condition presenting as follicular hyperkeratotic papules on proximal extremities. The appearance is disturbing to patients and current therapies are limited. Nitric oxide (NO) is essential in systemic and cutaneous physiologic function, specifically its anti-microbial and anti-inflammatory properties, which evolutionarily may have been maintained by ammonia-oxidizing bacteria (AOB). We hypothesized that topical skin application of AOB (Nitrosomonas eutropha), a biological delivery system of nitrite and NO, could benefit KP patients. We evaluated tolerability and efficacy in a double-bind, placebo-controlled, bilateral study in subjects with KP on both arms and legs.

Read More.

Funding to Advance Clinical Research on Systemic and Topical Inflammatory Disorders Using Novel Bacterial Platform

Leading microbiome company AOBiome announced it has partnered with iCarbonX, China’s largest health data collection and analysis platform. iCarbonX was founded in 2015 by renowned genomicist Jun Wang, whose iCarbonX ecosystem has made a $30 million investment in AOBiome. The investment reinforces the ascent of AOBiome as a leader in microbiome drug development, and is underscored by the recent launch of its Phase 2 clinical trial employing the company’s novel bacterial platform for treatment of hypertension. This is the second major clinical trial from AOBiome’s portfolio of therapeutic targets for ammonia-oxidizing bacteria (AOB), following the initiation of its acne vulgaris Phase 2B trial last fall. Once deployed, AOBiome’s proprietary AOBs consume ammonia and produce nitrite and nitric oxide, key signaling molecules known to regulate inflammation and vasodilation.

“Modern hygiene practices eliminate AOB’s that humans have co-evolved with. The loss of AOB’s may cause an imbalance in the nitrogen cycle, leading to excess ammonia and deficiencies in nitric oxide and nitrite, contributing to systemic inflammation,” said Todd Krueger, President of AOBiome. “iCarbonX is an ideal strategic partner to help us understand where and how repopulating AOBs has the potential to resolve a broad range of modern diseases and improve systemic health.” AOBiome is advancing a new Germ Theory of Health by reintroducing keystone commensal bacteria to our body’s natural microbiome. In the last 10 years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“iCarbonX and AOBiome share a mission to enable every individual to thoroughly manage their health and prevent disease. The fact that the AOB platform is poised to be the first FDA approved host regulated drug is a breakthrough in the concept of truly personalized medicine. That kind of groundbreaking work in biotechnology is at the heart of iCarbonX and its core values,” said Wang. BTIG served as a financial advisor to AOBiome during its fundraising efforts.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia oxidizing bacteria (AOBs) to the body, which current hygiene practices have stripped from the modern human microbiome. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock the company is developing a novel class of therapeutics to improve skin health, hypertension, and other systemic conditions. AOBs convert ammonia to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirt branded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.com. 

 

More Than 150M People Affected by Hypertension in the US Could Benefit From Patented AOB Treatment

Leading microbiome company AOBiome announced today the launch of its Phase 2 clinical trial using its first-in-class live bacteria (B244) for the treatment of hypertension. This is the second indication for AOBiome’s novel ammonia oxidizing bacteria following the enrollment of patients in its acne vulgaris trial earlier this fall. Once deployed on the skin, AOBiome’s proprietary ammonia oxidizing bacteria (AOBs) produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

AOBiome is exploring hypertension following the discovery of a correlation between the application of AOBs and blood pressure during AOBiome’s recent Phase 1B/2A acne study, for which blood pressure was tracked as a safety endpoint. Subsequent to this discovery, the company has brought on blood pressure experts to verify the B244 bacteria’s mechanism of action as it relates to the vascular system.

“In the two week, placebo-controlled safety study of the topical application of B244 bacterial mist on the face, we observed a dose-dependent reduction in blood pressure in normotensive subjects. The effect reached statistical significance at the highest treatment dose,” said Dr. Larry Weiss, Chief Medical Officer of AOBiome. “This study provides early insight into the potential that repopulating the microbiome with ammonia oxidizing bacteria has to treat disease and improve health.”

The Phase 2 hypertension study marks the advancement from the company’s successful acne vulgaris trial, which resulted in no serious adverse events, and no difference in adverse events between treatment and vehicle groups. Partnering with Veristat, the company will enroll 116 patients in a 28-day, double blind, placebo-controlled trial for the treatment of hypertensive patients.

“We have long postulated that delivering nitric oxide in host mediated environment would regulate blood pressure, but until the discovery of this bacteria, this has proven to be extremely difficult to achieve. This exciting breakthrough potentially provides us with a new modality of treatment for patients with pre-hypertension and the ability to improve blood pressure control in hypertensive patients without adversely impacting patient lives,” said hypertension specialist, Dr. Joel Neutel, who has performed over 500 blood pressure studies.

The company is advancing a new Germ Theory of Health by reintroducing ancestral keystone commensal bacteria to our body’s natural microbiome. In the last ten years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“Moving beyond dermal indications is an important step for AOBiome to show the breadth and power of restoring evolutionary levels of nitric oxide and nitrite to the entire system. There will be additional systemic clinical targets to come as we continue to follow the anti-inflammatory properties of our bacterial platform,” said Todd Krueger, President of AOBiome.

According to the CDC, there are 75 million patients currently being treated for hypertension and another 75 million pre-hypertensive patients in the United States who are hesitant to start blood pressure therapy due to the adverse effects of the current slate of antihypertensive medications. B244’s safety record and quick response profile makes this an ideal product to address this massive market. The company expects the FDA Phase 2 study to be completed before the end of 2017.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia-oxidizing bacteria (AOBs) which current hygiene practices have stripped from the modern microbiome. Founded in 2013 by MIT Chemical Engineer David Whitlock and Patients Like Me founder Jamie Heywood, the company is developing a novel class of therapeutics to improve skin health, hypertension, and other systemic conditions. AOBs convert ammonia to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirt branded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.com. 

Phase 2B Trial to Use Smartphones to Acquire Data with Partner Science37

Leading skin microbiome company AOBiome announced today the launch of its Phase 2B trial using its first-in-class live bacteria to treat acne. Phase 2B marks the advancement from the company’s successful Phase 1B/2A dose-ranging safety study, which resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. The Phase 2B trial is being jointly conducted with Science 37, a clinical research organization applying breakthrough telemedicine-based approach to bring clinical trials directly to patients’ homes. With approximately 372 adult patients enrolled for the treatment of mild-to-moderate acne vulgaris in adults with AOB, the trial will also employ smartphones for collecting real-time patient data – an industry first. The study is expected to be completed by Q3 of 2017.

“With the remarkable outcome of the Phase 1B/2A study, we are excited to see the results of this upcoming Phase 2B trial with Science37, which will feature one-to-one randomized, double-blind, and placebo controlled doses, over the course of 12 weeks. AOB’s unique safety profile allows us to reach more patients and to rapidly test for clinical efficacy across multiple disease states, with acne being the first,” says Chief Medical Officer Dr. Larry Weiss.

Acne is an inflammatory skin disease that currently affects an estimated 80 million Americans, and is the most common skin condition in the US. By treating acne with live, ammonia-oxidizing bacteria, AOBiome is setting the stage for the topical treatments and clinical trials of tomorrow. The company is advancing the conventional Germ Theory of Disease by reintroducing ancestral keystone commensal bacteria to our skin’s natural microbiome. In the last ten years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.

“We are excited to align Science 37’s next generation, technologically-enabled capabilities with AOBiome’s cutting edge approach to skin health. Through this partnership, AOBiome is able to engage with a significantly wider and more diverse population faster, and more cost effectively, than traditional methods,” says Todd Krueger, President of AOBiome.

Until now, the study of acne treatments largely depends on a dermatologist’s ability to count the number of breakouts on a patient’s face in person. Pervasive skin diseases like acne are great candidates for Science 37 teledermatology-based assessment. Teledermatology has been one of the most popular applications of e-health and telemedicine to capture information and visual data from dermatology patients, while tracking progress.

“With Science 37’s technology, decentralized operating model, and clinical trials management, the process to participate in this AOBiome trial will be much easier for patients, and unlocks their access to our expert Science 37 researchers around the country,” said Dr. Noah Craft, MD, PhD cofounder and CEO of Science 37. “We are thrilled to leverage emerging technologies and strategic partnerships with companies like AOBiome, which is committed to improve the lives of our patients and to accelerate finding new cures for the people that need them most.”

With the introduction of smartphones during the Phase 2B trial, patients can safely take part no matter their location, and using medications and iPhones shipped personally to them. The study is currently enrolling acne patients from 9 U.S. states.

About AOBiome
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia oxidizing bacteria (AOBs) which current hygiene practices have stripped from the modern microbiome. Founded in 2013, the company is developing a novel class of therapeutics to improve skin health as well as other systemic conditions. AOBs convert ammonia and urea in sweat to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirtbranded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.

About Science 37
Science 37 is a Los Angeles based technology-enabled clinical research company. They created a new clinical trial operating model – the metasite™ – that unlocks access so researchers can find the right patients, and patients can find the right trials. Their Network Oriented Research Assistant, NORA®, is the cloud-based patient-centric mobile research platform that connects everyone – safely and securely. Science 37 offers end-to-end clinical trial services without geographic limitations, making clinical research faster to accelerate biomedical discovery in all therapeutic areas. Ultimately, Science 37 enables better, faster people-powered science and brings clinical trials to scale. Learn more at Science37.