THE U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Zabalafin Hydrogel, a novel therapy designed to treat mild to moderate atopic dermatitis (AD) comprehensively. This innovative hydrogel directly addresses the bacterial imbalance, pruritus (itch), and immuno-inflammatory responses associated with AD, setting it apart from conventional treatments.
Zabalafin Hydrogel, developed as a first-in-class complex single-source botanical drug, leverages multiple bioactive compounds to provide anti-pruritic, antibacterial, and anti-inflammatory benefits. In two Phase IIa clinical trials, the treatment successfully met all primary and secondary endpoints, demonstrating clinically relevant improvements in itch relief, inflammation reduction, and patient quality of life, with minimal side effects and strong tolerability.
Atopic dermatitis, a chronic inflammatory skin condition affecting millions, often leads to significant discomfort and reduced quality of life due to persistent itching, inflammation, and frequent flare-ups driven by microbiome imbalances. Existing therapies primarily target isolated aspects of the disease, whereas Zabalafin Hydrogel’s multi-target approach offers a comprehensive solution.
With FDA clearance secured, a global Phase IIb clinical trial is expected to commence in the first quarter of 2025, advancing this potential breakthrough therapy toward broader clinical use.
Reference: Alphyn. Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment. February 19, 2025. Last accessed: February 21, 2025. Available at: https://alphynbiologics.com/press-release/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment/.
Anaya Malik | AMJ
