FDA Clears Zabalafin Hydrogel’s Investigational New Drug Application for AD

Image Credit: © Alyona Shu - stock.adobe.com

Alphyn Biologics announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin hydrogel, which is used to treat mild to moderate atopic dermatitis (AD).¹ This will be the first comprehensive therapy for AD that simultaneously addresses the bacterial and immuno-inflammatory aspects of the disease while also targeting pruritus.

"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," said Neal Koller, CEO of Alphyn. "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."¹

Zabalafin’s long-term safety and efficacy were demonstrated in a phase 2a trial, in which investigators observed clinically relevant improvements in itch, patient-assessed quality of life indications, inflammation, and safety when compared to baseline.²

About 90% of patients experienced a 1-point reduction in IGA score and a Patient Oriented Eczema Measure scale quality-of-life improvement of at least 6 by the end of treatment. Additionally, 68% of patients experienced an itch score improvement of at least 4, according to the Numerical Rating Scale, with 84% of patients with infected skin reaching complete clearance. All patients also had a decrease in Skin Infection Rating Scale score with only 1 reported treatment-emergent adverse event of mild transient stinging.

“There are well-known shortcomings with current atopic dermatitis therapeutics that, while effective, treat only the inflammatory component of the disease, and have side effects and safety warnings that restrict long-term and continuous use,” said Stephen Shumack, MD, principal investigator of the phase 2a trial, in last year’s press release. “This trial suggests that Zabalafin hydrogel could address these shortcomings by treating, in addition to AD's inflammatory component, both itch and AD’s bacterial component, which are known to be associated with AD flares. Importantly, Zabalafin hydrogel’s minimal side effect profile and excellent patient tolerability, combined with its efficacy, suggest it offers patients a worry-free option for continuous, long-term use.”²

Zabalafin hydrogel is a novel, first-in-class complex single-source botanical agent with “multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic, antibacterial, and anti-inflammatory activity,” according to Alphyn. Zabalafin hydrogel would be the first AD therapeutic to treat the bacterial complications of AD, specifically Staphylococcus aureus and methicillin-resistant Staphylococcus. The global Phase 2b trials of Zabalafin will begin later this year.

References

1. Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment. News release. PR Newswire. February 19, 2025. Accessed February 19, 2025. https://www.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html

2. Alphyn announces positive results from second cohort of phase 2a clinical trial in atopic dermatitis. News release. PR Newswire. March 7, 2024. Accessed February 19, 2025. https://www.prnewswire.com/news-releases/alphyn-announces-positive-results-from-second-cohort-of-phase-2a-clinical-trial-in-atopic-dermatitis-302082303.html