Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment

Zabalafin Hydrogel holds potential for first comprehensive AD treatment with safety and patient tolerability profile for long-term, worry-free, continuous use

ANNAPOLIS, Md., Feb. 19, 2025 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD's pruritus (itch), and directly treating the immuno-inflammatory cause of the disease.

"This is an incredibly important milestone for Alphyn, and a testament to the team's commitment to bringing to market a first-in-class treatment for a prevalent, chronic disease that substantially impacts patients' quality of life," said Alphyn CEO Neal Koller. "Zabalafin Hydrogel is on the cutting edge of an evolution in AD therapeutics to treat directly for the first time all aspects of the disease simultaneously. We believe it will be the compelling therapeutic choice to treat AD, offering excellent patient tolerability for worry free, long-term and continuous use, and comprehensive treatment for itch, inflammation, and managing the bacterial microbiome imbalance on the skin that exacerbates the disease and its flare-ups."

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. 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.

Zabalafin Hydrogel is derived from the company's Zabalafin Platform for multi-target therapeutics.

Alphyn anticipates the initiation of the global Phase 2b trials of Zabalafin Hydrogel in the first quarter of 2025.

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 the bacterial cause of AD, directly treating AD's pruritus (itch), and directly treating the immuno-inflammatory cause 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 $17 million.

SOURCE Alphyn Biologics, Inc.