New Research Highlights Zabalafin Hydrogel's Novel Multi-Targeted Approach to AD Treatment

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A recent paper published in the Journal of Drugs in Dermatology has highlighted Alphyn Biologics’ Zabalafin Hydrogel as a leading multi-target therapeutic for atopic dermatitis (AD).¹ Although no single product is effective against all typical manifestations of active AD, including pruritus, inflammation, damaged skin barrier, and Staphylococcus aureus (SA), Zabalafin Hydrogel shows promise as a novel, multi-targeted topical for the condition.

"This new paper highlights current dermatologists' thinking that treating the bacteria component of AD is as important as treating the immuno-inflammatory component of AD. It also highlights our Zabalafin Hydrogel as a powerful tool to help them directly treat all the problems of AD, importantly directly treating the key problem of itch,” Neal Koller, CEO of Alphyn, said in a statement.¹

Zabalafin Hydrogel is an investigational, first-in-class, botanical drug developed from Alphyn’s proprietary Multi-Target Therapeutics platform. The formulation integrates multiple naturally derived bioactive compounds that exert anti-inflammatory, anti-pruritic, and antibacterial effects, including anti-MRSA, to simultaneously disrupt the inflammatory cascade, reduce itch, and control bacterial involvement.

The paper presents a practical algorithm for the treatment of all stages of AD, including disease at the bacterial colonization stage, flaring disease, and AD at the infection stage.² It was developed by an expert team of 9 dermatologists: Lawrence A Schachner, MD, FAAD, FAAP; Adelaide A Hebert, MD, FAAD; Robert Sidbury, MD, FAAD, FAAP; Anneke Andriessen, PhD; Vanja Adzovic, PharmD; Mercedes E Gonzalez, MD, FAAD; Elizabeth Swanson, MD; Shawn G. Kwatra, MD; E. James Song, MD; Dennis West, PhD; and Peter Lio, MD, FAAD.

The investigators conducted a systematic literature review, focusing on the topical treatment of AD and SA-driven exacerbations. The literature search included 82 pieces of research, including studies and trials, clinical guidelines, consensus papers, and reviews published between January 2010 and January 2024. These results were then used to draft a practice-based algorithm based on evidence, experiences, and opinions.

The algorithm is divided into 2 sections: treating active AD flares with non-infected skin and treating secondarily infected AD flares. Assessment tools such as the Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and SCORing Atopic Dermatitis (SCORAD) scales should be used to evaluate AD severity and consider factors like xerosis, erythema, oozing, and lichenification. After a flare, dyschromia may persist, especially in patients with dark skin phototypes, and early treatment may mitigate inflammation and pigmentary sequelae, according to the panel.

In the Phase 2a trial, Zabalafin Hydrogel showed significant improvements in pruritus, inflammation, and patient-assessed quality of life. Particularly, the therapy has shown effectiveness in treating SA-associated complications of AD, demonstrating good control of SA and MRSA. This may address an unmet need for a single comprehensive therapy, as Zabalafin Hydrogel demonstrated promising results in modulating the SA component of AD, controlling SA-related flares and infections with minimal adverse events. Further research is needed to confirm these findings. The emerging treatment option is currently being evaluated in a global Phase 2b clinical trial program, with final results expected in the first half of 2026. The US FDA granted clearance for the company’s Investigational New Drug application in February of this year.³

"Topicals are the most highly prescribed therapeutic by dermatologists for AD and are an essential tool for treating the disease. They are the most preferred therapeutic by patients, especially children," said study author, Peter Lio, MD, FAAD. "That insurers are reimbursing new topical AD drugs highlights their importance, need, and value. This new algorithm is appropriately timed and needed to help focus diagnosis and treatment of AD at each of its disease stages - from onset through the AD bacterial colonization stage to AD infection stage, along with the inflammation and itch that are key parts of the disease. The potential for the new topical drug candidate Zabalafin Hydrogel to directly treat each of these AD disease stages is very encouraging."

References

1. Alphyn's Zabalafin Hydrogel for Atopic Dermatitis Highlighted in Leading Peer-Reviewed Journal. News release. PR Newswire. July 1, 2025. Accessed July 2, 2025. https://www.prnewswire.com/news-releases/alphyns-zabalafin-hydrogel-for-atopic-dermatitis-highlighted-in-leading-peer-reviewed-journal-302494942.html

2. Schachner LA, Hebert AA, Sidbury R, et al. Practical Algorithm on Topical Treatment of Flaring Atopic Dermatitis (AD) With or Without Secondary Infection. J Drugs Dermatol. 2025;24(6):621-630. doi:10.36849/JDD.8967

3. Alphyn secures FDA clearance of Investigational New Drug Application for atopic dermatitis treatment. News release. PR Newswire. February 19, 2025. Accessed July 2, 2025. https://www.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html