Alphyn's Zabalafin Hydrogel for Atopic Dermatitis Highlighted in Leading Peer-Reviewed Journal

• Expert dermatologist panel creates new atopic dermatitis (AD) algorithm (stepped diagnosis and treatment recommendations) emphasizing need for therapeutics that address AD's intense itch, inflammation, and the AD disease stages of Staphylococcus aureus (Staph) colonization through infection
  
  
• Panel underscores unmet need for topical multi-target therapeutic such as investigational new drug candidate Zabalafin Hydrogel to meet this need

ANNAPOLIS, Md., July 1, 2025 /PRNewswire/ -- Alphyn Biologics, Inc., a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that a groundbreaking paper has been published by an expert dermatologist panel providing a practical algorithm (stepped process to diagnosis and treat) for the topical treatment of atopic dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology. The paper addresses comprehensively treating AD's usually intense pruritus (itch), the immuno-inflammatory cause of the disease, and all stages of AD disease, including AD disease at bacterial colonization stage, flaring AD, and AD disease at infection stage.

The algorithm was developed by a panel of nine board-certified dermatologists and pediatric dermatologists. The authors report no single product is broadly effective against all typical manifestations of active AD: pruritus, inflammation, damaged skin barrier, and Staph at any of its AD disease impact stages. The authors conclude, "Our armamentarium now approaches the inclusion of a novel agent, Zabalafin Hydrogel … – a multi-targeted topical drug with mechanisms of action that provides antipruritic, anti-inflammatory, and broad anti-bacterial, including anti-MRSA, activity."

"Topicals are the most highly prescribed therapeutic by dermatologists for AD and are an essential tool for treating the disease. They are the most preferred therapeutic by patients, especially children," said Dr. Peter Lio, a board-certified dermatologist and one of the authors of the paper. "That insurers are reimbursing new topical AD drugs highlights their importance, need, and value. This new algorithm is appropriately timed and needed to help focus diagnosis and treatment of AD at each of its disease stages - from onset through the AD bacterial colonization stage to AD infection stage, along with the inflammation and itch that are key parts of the disease. The potential for the new topical drug candidate Zabalafin Hydrogel to directly treat each of these AD disease stages is very encouraging."

Alphyn CEO Neal Koller, added, "This new paper highlights current dermatologists' thinking that treating the bacteria component of AD is as important as treating the immuno-inflammatory component of AD. It also highlights our Zabalafin Hydrogel as a powerful tool to help them directly treat all the problems of AD, importantly directly treating the key problem of itch."

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 (anti-itch), antibacterial, and anti-inflammatory activity. It is derived from the company's Zabalafin Platform, a platform for first-in-class Multi-Target Therapeutics^®, that provides a deep and rich new drug candidate pipeline. The company has initiated a global Phase 2b clinical trial program of Zabalafin Hydrogel and expects to have final results in the first half of 2026.

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 and safety in Phase 2a clinical trials, suggesting it has the potential to be the first comprehensive AD treatment that is worry-free for long-term, continuous use. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating AD's pruritus, directly treating the bacterial component of AD, and directly treating the immuno-inflammatory component of the disease.

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 efficacy, safety, side effect, patient tolerability, 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 $21 million.

SOURCE Alphyn Biologics, Inc.