The FDA has cleared an Investigational New Drug (IND) application for Zabalafin Hydrogel, a botanical drug candidate targeting mild to moderate atopic dermatitis. The treatment, developed by Alphyn Biologics, Inc., addresses three components of atopic dermatitis: bacterial dysbiosis, pruritus, and inflammatory response. Phase 2a clinical trials demonstrated efficacy across all primary and secondary endpoints.
"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," stated Neal Koller, CEO of Alphyn Biologics. "We believe it will be the compelling therapeutic choice to treat AD, offering excellent patient tolerability for worry free, long-term and continuous use."
The treatment consists of multiple bioactive compounds derived from a single botanical source. These compounds produce antibacterial, antipruritic, and anti-inflammatory effects.
Phase 2a trials showed improvements in objective disease measures and patient-reported outcomes. Safety data indicated minimal adverse effects.
Alphyn Biologics plans to initiate global Phase 2b trials in Q1 2025. The company has raised approximately $17 million since becoming operational in 2020 and maintains subsidiaries in Australia and Austria.
Reference:
Alphyn Biologics, Inc. FDA clears investigational new drug application for atopic dermatitis treatment [news release]. PRNewswire. February 19, 2025. Accessed February 19, 2025. https://prnmedia.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html