Alphyn has announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel, a groundbreaking treatment for mild-to-moderate atopic dermatitis (AD).
This innovative therapy represents a significant advancement in AD treatment, addressing multiple aspects of the disease simultaneously. Zabalafin Hydrogel is designed to directly target AD’s underlying causes, including bacterial imbalances, inflammation, and persistent pruritus (itch), offering a comprehensive and multi-faceted approach to disease management with the potential to improve long-term patient outcomes.
Alphyn CEO Neal Koller, said, “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. 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.”
The therapy has already demonstrated strong potential in clinical testing, with two Phase 2a trials meeting all primary and secondary endpoints. These trials showed significant improvements in itch relief, inflammation reduction, and patient-reported quality-of-life measures, all while maintaining a strong safety profile with minimal side effects and excellent tolerability.
Alphyn plans to launch global Phase 2b trials of Zabalafin Hydrogel in the first quarter of 2025, marking the next step toward bringing this promising new treatment to patients in need.
Source:
- Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment. (n.d.). [Press release]. https://alphynbiologics.com/press-release/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment/
