Alphyn announced that the U.S. Patent and Trademark Office (USPTO) 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.
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