Alphyn Expands Patent Estate with New U.S. Patent for Atopic Dermatitis Therapeutic

Patent covers active pharmaceutical ingredient with protection until 2041

ANNAPOLIS, Md., Oct. 27, 2025 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted a patent for the active pharmaceutical ingredient (API) in its lead candidate for atopic dermatitis (AD). The patent complements Alphyn's previously issued U.S. patent protecting its Zabalafin Hydrogel drug products and expands the company's broader intellectual property portfolio.

"This is a significant achievement for Alphyn," said CEO Neal Koller. "Together with our previously issued patent for Zabalafin Hydrogel, we have broad protection for the product's composition and methods of use."

This new patent covers the topical use of Alphyn's drug raw material for the effective treatment of atopic dermatitis and provides protection until 2041. It supplements the company's U.S. Zabalafin Hydrogel patent that provides protection to 2043. Both patents will be eligible for listing in the U.S. Food and Drug Administration's (FDA's) Orange Book upon FDA approval of the AD drug. FDA Orange Book listing provides additional protections.

Alphyn has a growing patent portfolio covering its drugs and its Multi-Target Therapeutic Platform, with multiple applications filed globally. The company recently received a Notice of Allowance of Claims on a key patent for Zabalafin Hydrogel from the European Patent Office.

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.