Alphyn Biologics Announces Peer-Reviewed Paper Published in Journal of Drugs in Dermatology

Paper highlights Zabalafin Hydrogel's potential as a single topical atopic dermatitis therapy that impacts the Staphylococcus aureus component and treats all other disease symptoms across severity levels

ANNAPOLIS, Md., Nov. 1, 2024 /PRNewswire/ -- Alphyn Biologics, Inc., a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today the publication of a peer-reviewed paper in the Journal of Drugs in Dermatology that highlights the potential of Zabalafin Hydrogel to manage the Staphylococcus aureus (S. aureus)-driven mechanism behind atopic dermatitis (AD), as well as treat all the additional AD problems and severities, regardless of AD skin infection status. The paper, titled "A Consensus on Staphylococcus aureus Exacerbated Atopic Dermatitis and the Need for a Novel Treatment," underscores the importance of managing the S. aureus-driven causes of AD, S. aureus-related AD exacerbation,  and the S. aureus component in infected AD lesions to comprehensively treat AD.

The panel of six leading pediatric dermatologists who researched and authored the paper included Lawrence A. Schachner, MD., Mercedes E. Gonzalez, MD, Karan Lal, DO, Adelaide A. Hebert, MD, Lawrence F. Eichenfield, MD, and Peter Lio, MD, with the assistance of Anneke Andriessen, Ph.D. The group presented a consensus of five statements on S. aureus-driven AD exacerbation, challenges in current treatments for AD skin that is infected, and new developments to improve patient care and outcomes. The consensus statements offer recommendations for treating patients having infected AD skin and define a significant unmet need for a single topical AD therapeutic effective against all AD symptoms regardless of infection status, including AD pruritus, S. aureus-driven AD etiology and exacerbation, infected AD skin, and AD inflammation. The dermatologists reviewed data from Alphyn's Phase 2a clinical trials and used a modified Delphi process comprising face-to-face expert panel discussions and follow-up, along with a systemic literature review to inform their recommendations.

"The skin microbiome is essential for skin barrier function. Decreased diversity of the skin microbiome in AD correlates with increased S. aureus on AD skin and increased AD disease severity. Managing S. aureus on AD skin is therefore central to effectively treating this chronic condition, yet antibiotic stewardship is crucial," said Dr. Peter Lio. "The majority of today's AD therapies target only one aspect of AD, inflammation, while topical or systemic antibiotics treat AD skin infected by S. aureus and its drug-resistant strains such as MRSA. Zabalafin Hydrogel offers a promising alternative to anti-inflammatory and antibiotic drugs by treating all the aspects of AD, uniquely including S. aureus-driven AD and its symptoms, and addresses the unmet need for a single topical AD therapy that can treat the pruritus, inflammation, and dysbiosis without systemic side effects."

Alphyn Chief Scientific Officer Gary Pekoe, Ph.D., commented, "This paper authored by six of the most well-respected pediatric dermatologists strongly supports the evolution in AD treatment to focus on the bacterial cause of AD. Our Zabalafin Hydrogel is at the forefront of this treatment evolution, with its desirable properties of being natural based, treating the S. aureus AD problem directly, treating AD itch directly, and directly treating AD inflammation. The paper presents important insights into S. aureus-driven AD etiology and exacerbation, the challenges of treating AD-infected skin, and the need for an effective and comprehensive AD treatment that has a safety, side effect, and patient tolerability profile suitable for long-term and continuous use in the youngest of children."

Zabalafin Hydrogel is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic, antibacterial, and anti-inflammatory activity. Two Phase 2a clinical trials met all primary and secondary endpoints, showing clinically relevant improvements in itch, patient-assessed quality-of-life indicators, inflammation, and safety, with minimal side effects and strong patient tolerability. The company plans Phase 2b clinical trials next year to further demonstrate its potential as the drug of choice for AD. Zabalafin Hydrogel is derived from the company's Zabalafin Platform.

ABOUT ALPHYN BIOLOGICS
Alphyn Biologics, Inc. is a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^® for severe and prevalent skin diseases based on its Zabalafin Platform. Its lead product candidate, Zabalafin Hydrogel, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema.

Zabalafin Hydrogel has demonstrated strong efficacy in Phase 2a clinical trials, and the company believes it will be the first therapeutic for AD to directly treat AD's itch and directly treat bacteria that are increasingly thought to cause AD's inflammation and flares. It also directly treats infected AD skin and directly treats AD's inflammation. Clinical trial results of Zabalafin Hydrogel suggest it has the potential to be the first AD treatment that is worry-free for long-term, continuous use.

Alphyn's Zabalafin Platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential safety, side effect, patient tolerability, efficacy, and regulatory marketing authorization advantages. Alphyn is based in Annapolis, Maryland, and Cincinnati, Ohio, and has wholly owned subsidiaries in Australia and Austria. The company became operational in 2020 and has raised approximately $16 million.

SOURCE Alphyn Biologics, Inc.