FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic Dermatitis

An announcement by Alphyn Biologics, Inc., was release highlighting that the US Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for Zabalafin Hydrogel, a mild-to-moderate atopic dermatitis treatment option.1

As noted in the February 19 announcement, Zabalafin Hydrogel is distinctive in its approach to atopic dermatitis. Specifically, it is designed to address an array of aspects of atopic dermatitis simultaneously, reducing the characteristic pruritus associated with the condition, targeting the bacterial component of atopic dermatitis, and modulating the underlying immuno-inflammatory response.

"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," Alphyn CEO Neal Koller said in a statement. "Zabalafin Hydrogel is on the cutting edge of an evolution in [atopic dermatitis] therapeutics to treat directly for the first time all aspects of the disease simultaneously."1

Alphyn describes the hydrogel treatment as a comprehensive solution for atopic dermatitis, designed for patients’ continuous use without substantial risk. The hydrogel is a first-in-class botanical drug and contains multiple bioactive compounds that work through diverse mechanisms of action. For Zabalafin Hydrogel, some examples include antibacterial, anti-inflammatory, and anti-itch properties.

In a set of phase 2a clinical studies, investigators had been encouraged by Zabalafin Hydrogel’s strong efficacy and safety results, given that both of these studies’ primary and secondary endpoints had been met. Clinically significant improvements were reported among trial participants in inflammation, overall quality of life, and pruritus.

Additionally, findings from the phase 2a trials assessing Zabalafin Hydrogel suggested that the hydrogel had been well-tolerated and had few side effects. In Alphyn’s announcement, the company suggests that Zabalafin Hydrogel has the potential to become a breakthrough therapy for individuals suffering from atopic dermatitis.

The treatment was developed from the company’s Zabalafin Platform for multi-target therapeutics. The hydrogel is set to advance to global phase 2b research within the first quarter of 2025, suggesting a step is being made toward a broader clinical evaluation of the medication and potential availability down the line. The drug’s clearance adds to the list of February’s FDA announcements regarding atopic dermatitis research.2

“We believe it will be the compelling therapeutic choice to treat [atopic dermatitis], 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,” Koller said in his statement.1

References

1. Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment. Alphyn Biologics, Inc. 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. Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis. Nektar Therapeutics. February 10, 2025. https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-302371995.html.