The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Alphyn’s Zabalafin Hydrogel for the treatment of mild-to-moderate atopic dermatitis (AD).
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, 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.
“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,” says Alphyn CEO Neal Koller, in a news release. “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.”
