Alphyn Granted U.S. Patent Covering First-in-Class Treatment for Atopic Dermatitis

Patent covers compositions and methods of use of drug formulation for Zabalafin Hydrogel

ANNAPOLIS, Md., Dec. 10, 2024 /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 the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration's (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.

"Zabalafin Hydrogel fills a significant unmet need for a single topical AD treatment and for the first time demonstrates the potential to manage all of the problems and causes of AD, uniquely including the bacteria-driven cause of AD, specifically the bacteria Staphylococcus aureus (S. aureus). It has shown that it addresses quite effectively the top AD treatment priority of itch, as well as AD inflammation, and is the only treatment in development to treat AD skin that is infected and non-infected, with excellent patient tolerability," said Alphyn CEO Neal Koller. "This patent offers broad protection for Zabalafin Hydrogel as we advance Phase 2b clinical trials and continue to build our intellectual property portfolio for Zabalafin Hydrogel and our Zabalafin Platform globally."

Zabalafin Hydrogel is a novel complex single-source botanical first-in-class drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic, antibacterial, and anti-inflammatory activity. It is Alphyn's lead product candidate, and the company expects to begin Phase 2b clinical trials of Zabalafin Hydrogel in the United States, Europe, and Australia in the first half of 2025.

Two AD Phase 2a clinical trials have been completed, demonstrating significant and clinically relevant improvements in itch, patient-assessed quality-of-life indicators, inflammation, and safety, with minimal side effects and strong patient tolerability. In November, Alphyn announced the first peer-reviewed article published by leading dermatologists in the Journal of Drugs in Dermatology, highlighting the potential of Zabalafin Hydrogel to treat all the problems of AD.

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