Zabalafin Hydrogel Shows Efficacy in Atopic Dermatitis, Including Cases with Bacterial Infection

© Alphyn Biologics

Alphyn Biologics presented new data supporting the safety and efficacy of Zabalafin Hydrogel for atopic dermatitis (AD) at the 2025 American Academy of Dermatology Annual Meeting in Orlando, according to a company news release.¹

The poster highlights Phase 2a trial results demonstrating significant improvements in itch, bacterial-associated flares (including MRSA infection), and inflammation, suggesting this topical therapy may offer a single, comprehensive approach to manage AD across multiple disease stages.¹

"The results for the entire Phase 2a clinical program, presented together for the first time at AAD, illustrate the potential of Zabalafin Hydrogel to overcome the shortcomings of current AD therapeutics to offer a single, comprehensive AD treatment that is suitable for long-term, worry-free, continuous use," said Alphyn CEO Neal Koller in a news reelase. "We're excited to begin our global Phase 2b clinical trial program shortly, to advance our goal of developing new, multi-target therapeutics for chronic, serious, and prevalent diseases, beginning with AD."¹

The Phase 2a program encompassed two cohorts of patients with mild to moderate AD, each at a distinct stage of disease progression influenced by bacterial involvement. Cohort A included patients for whom bacteria contributed to AD progression but had not yet advanced to overt infection. This randomized, double-blind, vehicle-controlled study (ages 2-66) showed that twice-daily application of Zabalafin Hydrogel significantly outperformed vehicle at Week 4, with no safety concerns.¹

Meanwhile, Cohort B were patients whose AD had progressed to infection, including MRSA (methicillin-resistant Staphylococcus aureus). This open-label study of patients aged 3 to 63 followed patients for 8 or 12 weeks of twice-daily treatment. Patients experienced a substantial decrease in itch, with 68% achieving a reduction of ≥4 points on the Pruritus Numerical Rating Scale by Week 12.¹

Improvements in quality of life were similarly impressive: 89% of patients attained a ≥6-point improvement in the Patient Oriented Eczema Measure (POEM). In terms of clinical signs, 50% of participants reached an Investigator’s Global Assessment (IGA) score of clear or almost clear (IGA 0 or 1) with a ≥2-grade improvement at Week 12. The Eczema Area and Severity Index (EASI) further demonstrated strong responses, with 79% attaining at least 50% improvement (EASI50), 47% attaining at least 75% improvement (EASI75), and 10% achieving complete lesion clearance (EASI100) by Week 12.¹

Notably, Zabalafin Hydrogel also cleared AD-related infections in 84% of patients, and was successful in 100% of cases where the infection was caused by methicillin-resistant Staphylococcus aureus (MRSA). Throughout the program, only one mild adverse event, transient stinging, was reported, and it did not necessitate discontinuation of treatment.

Zabalafin Hydrogel, derived from Alphyn’s proprietary Zabalafin platform, is a complex botanical drug containing multiple bioactive compounds that address distinct pathogenic pathways in AD.¹ It exhibits anti-itch, antibacterial, and anti-inflammatory activities, positioning it as a “multi-target therapeutic” and potentially reducing the need for combination regimens often required for atopic dermatitis with secondary infection.

In February, Alphyn announced that the US Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for Zabalafin Hydrogel, enabling the company to initiate clinical evaluation of its safety, tolerability, and efficacy.²

Reference

1. Alphyn Biologics, Inc. Alphyn Poster at American Academy of Dermatology Annual Meeting Highlights Potential of Zabalafin Hydrogel as Singular, Comprehensive Treatment for Atopic Dermatitis. News release. March 10, 2025. Accessed March 10, 2025. https://prnmedia.prnewswire.com/news-releases/alphyn-poster-at-american-academy-of-dermatology-annual-meeting-highlights-potential-of-zabalafin-hydrogel-as-singular-comprehensive-treatment-for-atopic-dermatitis-302396484.html
2. Alphyn Biologics, Inc. Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment [news release]. February 19, 2025. Accessed March 10, 2025. https://prnmedia.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html.