FDA Clears IND for Alphyn’s Zabalafin Hydrogel for Atopic Dermatitis

The US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application submitted by Alphyn Biologics for Zabalafin Hydrogel, a topical therapy intended for the treatment of mild to moderate atopic dermatitis (AD).1

The clearance enables Alphyn to initiate global phase 2b clinical trials, which are anticipated to begin in the first quarter of 2025. The company was granted a US patent in December 2024 covering first in class treatment for AD, according to an earlier press release.2

Zabalafin Hydrogel is formulated as a complex, single-source botanical drug that contains multiple bioactive compounds. According to the company, these compounds directly target the multifactorial pathophysiology of AD, including pruritus, bacterial imbalance, and immunoinflammatory processes. The phase 2a trials met both primary and secondary endpoints, showing clinically relevant improvements in itch relief, patient-assessed quality-of-life measures, and skin inflammation. The treatment was also associated with minimal adverse events and favorable patient tolerability.1

In November, Alphyn announced the first peer-reviewed article published by leading dermatologists in the Journal of Drugs in Dermatology.3

“The skin microbiome is essential for skin barrier function. Decreased diversity of the skin microbiome in AD correlates with increased S. aureus on AD skin and increased AD disease severity. Managing S. aureus on AD skin is therefore central to effectively treating this chronic condition, yet antibiotic stewardship is crucial,” Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, said in a November press release.3 

“The majority of today’s AD therapies target only one aspect of AD, inflammation, while topical or systemic antibiotics treat AD skin infected by S. aureus and its drug-resistant strains such as MRSA. Zabalafin Hydrogel offers a promising alternative to anti-inflammatory and antibiotic drugs by treating all the aspects of AD, uniquely including S. aureus-driven AD and its symptoms, and addresses the unmet need for a single topical AD therapy that can treat the pruritus, inflammation, and dysbiosis without systemic side effects.”3

AD, the most common form of eczema, often presents with recurrent pruritus, inflammation, and compromised skin barrier function. Existing treatments target isolated aspects of the disease, while Zabalafin Hydrogel aims to address multiple components of AD pathology in a single agent. Alphyn notes that its Zabalafin Platform — on which Zabalafin Hydrogel is based — incorporates a broad spectrum of mechanisms of action for dermatologic therapeutics.1

"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 Alphyn CEO Neal Koller. We believe [Zabalafin Hydrogel ] 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

References

1 Alphyn secures FDA clearance of Investigational New Drug application for atopic dermatitis treatment. News release. Alphyn. Published February 19, 2025. Accessed February 20, 2025. https://alphynbiologics.com/press-release/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment/

2 Alphyn granted US patent covering first-in-class treatment for atopic dermatitis. News release. Alphyn. December 10, 2024. Accessed February 20, 2025. https://alphynbiologics.com/press-release/alphyn-granted-u-s-patent-covering-first-in-class-treatment-for-atopic-dermatitis/

3 Alphyn Biologics announces peer-reviewed paper published in Journal of Drugs in Dermatology. News release. Alphyn Biologics. November 1, 2024. Accessed February 20, 2025. https://alphynbiologics.com/press-release/alphyn-biologics-announces-peer-reviewed-paper-published-in-journal-of-drugs-in-dermatology/