Press Releases

AOB Pharma and Biorasi to Partner to run Phase 2b in Moderate to Severe Acne

Following encouraging earlier-phase clinical data, the Company is advancing its acne trial ahead of schedule while maintaining atopic dermatitis global Phase 3 timeline.

CAMBRIDGE, Mass., July 1, 2026 /PRNewswire/ — AOB Pharma, Inc. (“AOBiome”), a leading clinical-stage biotechnology company focusing on inflammatory skin conditions, announced that it has partnered with Biorasi, a Clinical Research Organization to start the process of executing on its Phase 2b clinical trial in moderate to severe acne vulgaris. The Company previously partnered with Biorasi to run its global Phase 3 study in atopic dermatitis (“B244”) in 2027. B244 had shown encouraging signals in earlier-phase studies in mild to moderate acne previously. Based on the clinical data generated to date and the significant unmet need in moderate to severe acne, the company has elected to focus its Phase 2b program on this patient population.

“B244 has generated encouraging data in earlier studies, and I’m excited to see it being evaluated in patients with moderate to severe acne. Despite the number of available acne treatments, many patients continue to struggle with disease control, treatment tolerability, and safety concerns, so B244 has the potential to provide an important new treatment option,” says Peter Lio, MD, Founding Partner, Medical Dermatology Associates of Chicago.

“We look forward to our continued relationship with Biorasi. They previously executed our Phase 2b study and we look forward to running another trial focused on an indication where patients would benefit from additional treatment options,” says Todd Krueger, CEO and President of AOB Pharma.

Biorasi President, Melissa Alesse, adds “AOBiome’s decision to advance this program reflects confidence in both their clinical strategy and pipeline. We are pleased to continue our partnership and are ready to execute with discipline, reliability, and proven operational excellence.”

Accelerating the Phase 2 acne program is expected to offer several potential benefits, including:

  • Earlier data readout: Beginning the trial this fall positions AOBiome to generate Phase 2 results sooner, potentially enabling a faster path to Phase 3 and, ultimately, subsequent regulatory milestones.

  • Expanded pipeline momentum: Running acne and Atopic Dermatitis programs concurrently demonstrates the company’s ability to advance multiple indications simultaneously, strengthening its clinical portfolio.

  • Significant unmet need: Acne affects an estimated 50 million Americans annually, and new therapeutic options — particularly those with novel mechanisms of action — are needed for patients who do not respond adequately to existing treatments or have issues with the side effect profile of existing drugs.

  • Novel MoA designed to target anti-inflammatory activity, sebum production, and C. acnes, with earlier-phase clinical data supporting further evaluation.

  • Competitive positioning: An earlier start improves AOBiome’s position in the acne therapeutics landscape and could accelerate future business development opportunities.

The Phase 2 acne trial is expected to enroll 176 patients across 13 clinical sites. The Company intends to submit its new Phase 2b protocol to the FDA under its existing IND on July 10th. Full details of the trial design will be made available later this year.

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, published immunology data has shown that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31 (Bhatt et al., Scientific Reports, 2021). See full article at: https://www.nature.com/articles/s41598-021-93299-1

About AOBiome

AOB Pharma is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

About Biorasi

Biorasi is a global clinical research organization designed for emerging and mid-sized biopharma companies. Biorasi integrate closely with sponsors to support confident clinical trials by combining experienced operational leadership with fit-for-purpose delivery models and real-time transparency. Learn more at www.biorasi.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied. Forward-looking statements include, but are not limited to, statements regarding expected timelines, enrollment targets, clinical trial design, anticipated benefits of B244, and the potential for regulatory submissions or approvals. Neither AOBiome nor Biorasi undertakes any obligation to update any forward-looking statement. These statements should not be relied upon as representing the views of either company as of any date subsequent to the date of this press release.

Contacts:

For Media Inquiries:
Jim Hoffman
+1.617.639.9980
Press@AOBiome.com

For Biorasi Inquiries:
Adam Gottlieb, Head of Marketing
(954) 410-3654
agottlieb@biorasi.com

SOURCE AOBiome Therapeutics

AOBiome Featured in BioXconomy

The power of strategic partnerships: How Veristat and AO Biome redefined CRO-sponsor collaboration

In an exclusive interview with BioXconomy, Kim Boericke, COO at Veristat, and Hyun Kim, senior vice president of clinical development at AO Biome, offer insights into their collaboration and how CRO-sponsor partnerships can overcome challenges, accelerate development, and build investor confidence.

Read the full article

Veristat and AOBiome Therapeutics to Present at Clinical Outsourcing Group on Essential Elements of Effective Partnerships with CROs

Southborough, MA – Oct. 7, 2025 – Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced today that it will participate in the Clinical Outsourcing Group – Bay Area 2025 conference, taking place October 21-22, 2025 at the Hyatt Regency San Francisco Airport, Burlingame, CA. Veristat is speaking with AOBiome Therapeutics, a clinical-stage biotech company focusing on inflammatory conditions, on October 21 at 4:45 p.m. PT and will address how early integration and honest, sometimes difficult conversations between sponsors and CROs can improve trial success.

As the biotech industry continues to evolve, many sponsor-CRO relationships remain transactional and fail to deliver the strategic collaboration needed for successful drug development. Veristat COO Kim Boericke and AOBiome Therapeutics Senior Vice President of clinical development Hyun Kim will  discuss this longstanding barrier in their session titled, “Strategic from the Start: Leveraging Your CRO as a True Development Partner.” Together, they will explore the challenges and benefits of transforming CRO relationships into true partnerships that guide programs from funding through clinical development and regulatory approval.

“I look forward to this important discussion, as CROs often tell sponsors what they want to hear rather than what they need to hear,” said Boericke. “Strategic partnerships require transparency, shared accountability, and the courage to have difficult conversations to prevent regulatory delays and failed trials.”

The session will also dive into the “uncomfortable realities” of clinical development that many CROs avoid discussing – including unrealistic timelines, flawed study designs, and regulatory blind spots. Attendees will gain insights into how proactive, integrated collaboration can help avoid costly setbacks and improve the chances of regulatory approval.

AOBiome Therapeutic’s Kim will also share firsthand experience successfully collaborating with Veristat over nearly a decade. The company first partnered with Veristat in 2016 to support clinical development across multiple disease areas, including hypertension, eczema, and migraine. The strategic partnership has expanded to collaborate on five clinical studies from Phase 2 through registration, with Veristat providing comprehensive services including statistical consulting, regulatory strategy, and trial delivery.

“What sets a strategic CRO partnership apart is not just expertise, but also alignment—on priorities, risk tolerance, and decision-making speed,” said Kim. “With Veristat, we’ve been able to move faster and smarter because they operate as an extension of our team, not a vendor.”

Schedule a meeting with Veristat and AOBiome here or visit Veristat at the Clinical Outsourcing Group conference in Burlingame, CA in October.

About AOBiome Therapeutics
AOBiome Therapeutics is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates.
Learn more at www.aobiome.com.

About Veristat
Veristat
is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide.
For more information, visit www.veristat.com

 

Media Contact
Lisa Barbadora, Barbadora INK for Veristat
+1 (610) 420-3413
lbarbadora@barbadoraink.com

AOB Pharma reveals new mechanistic insights via metabolomic analysis of B244, supporting clinical readouts and suggesting investigation of potential new avenues for treatment

AOB Pharma reveals new mechanistic insights via metabolomic analysis of B244, supporting clinical readouts and suggesting investigation of potential new avenues for treatment

  • B244 produces numerous skin-beneficial metabolites including ceramides, retinoids, tocopherol, and niacinamide
  • The presence of these anti-inflammatory and skin-beneficial compounds suggest additional ways that B244 can improve atopic dermatitis and other inflammatory skin diseases
  • Mining of additional metabolomic data may additionally suggest new indications for which B244 can be used
  • Select data will be presented by Dan Brownell, AOBiome’s Senior Director of R&D, at the Dermatology Drug Development Summit Europe, taking place in Berlin May 27-28, 2025

CAMBRIDGE, MA, May 21, 2025. AOB Pharma, Inc. (“AOBiome”), a leading clinical-stage biotechnology company focusing on inflammatory skin conditions, shares new data showing that B244, their lead asset, secretes a suite of anti-inflammatory and beneficial skin metabolites. Metabolomic analysis of B244 has revealed the production of various ceramides, retinoids, tocopherol, niacinamide, and many other compounds critical for skin health. These compounds, in addition to the previously understood mechanisms of action, further highlight the multifactorial benefits of B244 for the potential treatment of additional inflammatory diseases.

Ceramides are essential lipids that help maintain the skin’s natural barrier, which is often compromised in people with atopic dermatitis. By replenishing ceramide levels, the skin can maintain moisture, reduce dryness, and protect the skin from irritants and allergens. This strengthens the skin’s defense, soothes inflammation, and reduces flare-ups, making ceramides a tool in the maintenance of skin health. Other metabolites produced by B244 have similar potential benefits that justify investigation for use in treatment, including reducing inflammation, antioxidant effects, improvement in skin appearance associated with various skin disorders.

“B244 is clearly more than simply a probiotic: these active metabolites have the potential to support the skin in multiple ways simultaneously, unlike any product currently in the marketplace. There is tremendous potential here to revolutionize our understanding of the role of bacteria in skin health and resilience” says Peter Lio, MD, Founding Partner, Medical Dermatology Associates of Chicago.

AOBiome is currently preparing to initiate a global Phase 3 study to evaluate B244 for the treatment of mild-to-moderate Atopic Dermatitis and associated moderate-to-severe itch, following the successful completion of a 547 patient Phase 2b study. In addition to the previously understood mechanisms of B244, these new metabolomic insights further suggest the range of improvements of AD symptoms seen clinically.

“From an evolutionary standpoint, this further highlights the potential need for ammonia oxidizing bacteria for not only maintaining healthy skin, but treating inflammatory conditions that we did not evolve to have” says President and CEO Todd Krueger.

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOB Pharma, Inc.

AOB Pharma, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Jim Hoffman
+1.617.639.9980
Press@AOBiome.com

USPTO Grants AOBiome Therapeutics Composition of Matter Patent for its Clinical Candidate B244

  • The newly issued patent covers Composition of Matter for AOBiome’s proprietary strain of Ammonia Oxidizing Bacteria (AOB), along with additional claims pertaining to a variety of related methods including use thereof in changing a composition of a skin microbiome of a subject, inhibiting microbial growth on a subject’s skin, and treating or preventing a skin disorder.
  • AOBiome’s clinical candidate B244 has demonstrated clinical efficacy on multiple therapeutic indications including: Mild-to-Moderate Atopic Dermatitis (Eczema) and associated Moderate-to-Severe Pruritus (Itch), and mild-to-moderate Acne Vulgaris (Acne)
  • AOBiome is currently preparing for its Global Phase 3 trial for the treatment of Atopic Dermatitis and associated Pruritus, as well as a Phase 2 study in moderate to severe Acne Vulgaris

CAMBRIDGE, Mass., October 2, 2024 /EIN Presswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage biotech company focusing on inflammatory conditions, today announced that the United States Patent Office (USPTO) has issued a composition of matter patent, U.S. Patent No. 12,091,652, with claims focused on its proprietary strain of beneficial AOB (Ammonia Oxidizing Bacteria), in the class of Nitrosomonas eutropha. The base patent term extends until November 3, 2035, excluding patent term extensions or coverage in additional related patent filings.

AOBiome’s B244 proprietary strain is delivered via a simple to use topical spray.  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.  It has also been demonstrated that this strain of AOB can reduce the inflammatory and pruritic cytokines, including IL-4, IL-5, IL-13, and IL-31 which are hallmarks of atopic response.

The Company completed a Phase 2b study of 547 patients with mild-to-moderate atopic dermatitis and associated moderate-to-severe pruritus. B244 showed continued durability of treatment effect and separation from placebo post-treatment of 41.1% reduction in itch from baseline at 8 weeks, 4 weeks after the last dose.  This and other clinical trials have also demonstrated the unique safety profile of B244, with no treatment related SAE’s reported on any of the over 1,000+ patients that have participated in its trials.

This issuance follows the granting of the patent in numerous non-US territories including: Australia, Canada, China, France, Germany, Hong Kong, India, Japan, Korea and United Kingdom. The composition of matter patent gives an extra measure of protection to the already issued use patents that cover the clinical areas the company is pursuing, including Acne, Atopic Dermatitis, Rosacea, Psoriasis and other inflammatory skin diseases.   AOBiome has also been granted other patents, in the US and internationally, covering manufacturing, quality assurance and product delivery.

“Getting a composition of matter patent speaks to the unique aspects of this proprietary strain of AOB which has shown superior growth, stability and metabolic activity when compared to other strains.  This coupled with our existing issued use patents for the entire class of AOB gives us a unique position in the marketplace” says President & CEO, Todd Krueger.

AOBiome is currently preparing for its Global Phase 3 trial for the treatment of Atopic Dermatitis (Eczema) and associated Pruritus (Itch).  The Phase 3 trial will include 2 arms of 934 each with a 900 person OLE.  The trial will study both Adults and Children down to the age of 12 years.  A follow-on study is planned for children down to the of 3 months.  The trial will be run in the US, Europe and Japan in conjunction with AOBiome’s licensing partner Maruho.

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOBiome Therapeutics, Inc.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

Contacts:

For Media Inquiries:
Jim Hoffman
+1.617.639.9980
Press@AOBiome.com

AOBiome and Maruho have entered into an Exclusive License Agreement for a Novel Therapeutic for the treatment of Atopic Dermatitis in Japan

Osaka (Japan), January 10, 2024 – Maruho Co., Ltd. (“Maruho”; Head Office: Osaka; President and CEO, Atsushi Sugita) announces that it has entered into an exclusive license agreement (the “Agreement”) with AOBiome, LLC (“AOBiome”, Head Office: Cambridge, Massachusetts (USA); President and CEO, Todd Krueger) for B244 (development code) for the treatment of atopic dermatitis.

Under the license agreement, AOBiome grants Maruho an exclusive license to develop, manufacture, and commercialize B244 in Japan, and Maruho will pay AOBiome an upfront payment. Maruho may also make additional milestone payments depending on achievement of development and commercialization milestones. Maruho also has the rights to B244 for additional diseases other than atopic dermatitis.

Maruho plans to advance the development of B244 in Japan by participating in the global Phase 3 clinical studies that AOBiome is planning in Japan, the U.S. and Europe for the treatment of adult patients with atopic dermatitis.

B244 is a topical biologic formulation being developed by AOBiome, leveraging ammonia-oxidizing bacterium. B244 reduces the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-311). In a late stage Phase 2 clinical study conducted in the U.S. by AOBiome in adult patients with atopic dermatitis, B244 was found to be safe and effective for the treatment of appearance and itching related to atopic dermatis2).

Maruho is committed to contributing to the smiles of patients by providing a new treatment option for atopic dermatitis.

NoteThe information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice.
About AOBiomeAOBiome, LLC. is a Cambridge, MA-based life sciences company. AOBiome is engaged in the development of topical therapeutics for inflammatory conditions using its live biotherapeutic B244. For more information, please visit https://www.aobiome.com/
About Ammonia Oxidizing BacteriaAmmonia Oxidizing Bacteria is a general term for bacteria that oxidize ammonia to nitric oxide and nitrite. The genus Nitrosomonas is a representative example.
About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ended September 30, 2023. With the mission “More smiles, brighter life for you.”, Maruho aims to help realize a society where everyone can live with a smile.
For more information, please visit www.maruho.co.jp/english/
References1)https://www.aobiome.com/aob-inflammatory-conditions-and-systemic-effects/
2)https://www.aobiome.com/press/press-releases/?y=2023
Contact Information:
Maruho Co., Ltd.
Public Relations Group, Corporate Planning Dept.
Tel:+81-(0)6-6371-8831
Fax:+81-(0)6-6371-8679
e-mail:kouhou@mii.maruho.co.jp

AOB Pharma and Maruho enter into an Exclusive License Agreement for AOB Pharma’s Topical Biologic B244 for the Treatment of Inflammatory Indications including Atopic Dermatitis in Japan

  • The license is exclusive for the territory of Japan and contains rights for future indications
  • Maruho is responsible for conducting and bearing costs for development in Japan, which will be conducted jointly with AOB Pharma as part of a Global Phase 3 Study for Atopic Dermatitis encompassing Japan, the US, and EU
  • The deal includes upfront payments, milestone payments and ongoing royalties.

CAMBRIDGE, Mass., January 5, 2024 /PRNewswire/ — AOBiome Therapeutics Inc. (“AOB”), a leading clinical-stage microbiome company focusing on inflammatory conditions, announced today that is has entered into an exclusive license and development agreement with Maruho Co., Ltd., to develop and commercialize AOB’s topical biologic B244 (currently preparing for global Phase 3 clinical trials), a therapeutic treatment for dermatological indications including Atopic Dermatitis, for both appearance and pruritus (itch).   The license is for all indications treated by the B244 platform.

Under the license agreement, Maruho will commercialize the product exclusively in Japan. Based on the license agreement, AOB will supply the product to Maruho, and Maruho will make an upfront payment and may also make additional milestone payments depending on achievement of development and commercialization milestones.  Maruho also has the rights to AOB’s B244 for all additional indications including later stage programs related to inflammation.

“B244 offers an opportunity to extend our portfolio for the treatment of Atopic Dermatitis as well as other inflammatory indications.  It’s unique safety profile and efficacy will allow us to continue our leadership in treating Atopic Dermatitis while improving patients’ lives.  We look forward to continuing to develop the treatment in collaboration with AOB Pharma.” says Atsushi Sugita, President and CEO of Maruho.

“We are excited to be partnering with Maruho as they are the leading dermatology player in Japan.  We view this as validation of B244’s potential to address unmet market needs, not just in Japan but globally.  We could not have found a better collaborator as we develop our programs for Japanese patients.  This model will serve as an example as we fill out our worldwide strategy.” says AOBiome’s President & CEO, Todd Krueger.

AOB is in the process of planning global Phase 3 studies for B244 in Atopic Dermatitis, for which it aims to start recruiting patients in the second half 2024.  The Japanese portion of the Phase 3 trials will be run in Japan by Maruho.

About B244

AOB’s B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31.  See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOB Therapeutics, Inc.

AOBiome Therapeutics Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOB is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at AOBPharma.com.

About Maruho

Maruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,547 employees (as of the end of September 2022), and net sales were approximately 85.67 billion yen in its fiscal year ended September 30, 2022. With the mission “More smiles, brighter life for you.”, Maruho aims to help realize a society where everyone can live with a smile.

For more information, please visit https://www.maruho.co.jp/english/

Contacts:

For Media Inquiries:

Jim Hoffman

845-417-3487

Press@AOBiome.com

SOURCE AOBiome Therapeutics

AOBiome announces the publication of positive Phase 2b results in The Lancet’s eClinicalMedicine for B244 in the treatment of mild-to-moderate atopic dermatitis and moderate-to-severe pruritus

  • The peer-reviewed publication describes the significant effects of B244 in 4 weeks across key endpoints in adult patients with atopic dermatitis and associated pruritus (itch) in the largest study of B244 to date.
  • The study demonstrated significant efficacy of B244 across all clinical endpoints, including the improvement of itch, eczema severity, and quality of life metrics.
  • Study results reiterate B244’s strong safety profile at all dose levels, confirming prior clinical trial safety results.
  • B224 is an investigational therapy currently under regulatory review in the U.S. These study results support the advancement of B244 to Phase 3.

CAMBRIDGE, Mass., May 16, 2023 /PRNewswire/ — AOBiome Therapeutics, Inc. (“AOBiome”), a leading clinical-stage biotech company focusing on inflammatory conditions, today announces that The Lancet’s eClinicalMedicine, a peer-reviewed medical journal, has published a report describing the Company’s Phase 2b clinical data for its B244 treatment for mild-to-moderate atopic dermatitis and moderate-to-severe pruritus. The paper, titled “Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial,” provides a detailed analysis of the Phase 2b trial, showing that B244 demonstrated significant improvements in eczema severity and itch reduction. The article can be freely accessed  via the following link: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00179-7/fulltext

In the trial, 547 patients were assigned to a high-dose, low-dose, or placebo group. The trial was run across more than 50 clinical sites in the US, in collaboration with Biorasi, LLC, a leading Clinical Research Organization. After 4 weeks of use, the following key results were obtained:

  • Itch was reduced by 34% (-2.8 B244 vs -2.1 Placebo) compared to placebo, as measured by the Worst Itch Numeric Rating Score (WI-NRS) and achieved a clinically meaningful itch response (30.8% B244 vs 21.8% Placebo in ≥4-point improvement in WI-NRS from baseline).
  • Eczema severity improvements were also seen, with 29.3% and 27.7% of patients in the high and low dose groups of B244 achieving EASI-75 success vs. 15.8% in the placebo group and with 26.2% and 21.7% of patients in the high and low dose groups of B244 achieving IGA success (≥2-point improvement in IGA to clear or almost clear) vs. 12.3% in the placebo group.
  • B244 was well-tolerated, with no serious adverse events. Treatment-emergent adverse events (TEAE) and treatment-related TEAEs were infrequent, mild, and transient.

Dr. Jonathan Silverberg, Director of Clinical Research at the George Washington University School of Medicine and Health Sciences, says “B244 is a promising new non-steroidal therapy for AD, with a very novel mechanism of action. The study was well designed and the results are very promising. B244 may address a number of unmet needs for atopic dermatitis patients.”

According to Todd Krueger, President and CEO of AOBiome Therapeutics, Inc., “This publication represents the recognition of B244’s efficacy and differentiation in addressing this population.  The fact it has so few side effects reinforces the commercial opportunity to become first line therapy before patients escalate to more expensive, risky, or invasive therapies.”

About B244

AOBiome’s B244 platform is a patented, proprietary, topical formulation of ammonia oxidizing bacteria. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, and IL-13. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOBiome Therapeutics, Inc.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

About Biorasi

Biorasi is a customer-focused, full-service, contract research organization (CRO) that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors. As the leader in clinical trials for dermatology, neurology, oncology, and the rare disease market, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences. Contact Biorasi at info@biorasi.com / (786) 388-0700 or visit us online at www.biorasi.com.

Contacts:

For Media Inquiries:
Jim Hoffman
845-417-3487
Press@AOBiome.com