IGA, EASI, and Itch Endpoints Met in First In Human Phase 2 Trial of Zabalafin for Atopic Dermatitis

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Zabalafin (AB-101a), a novel topical drug, met primary and secondary endpoints of IGA improvement, EASI improvement, itch reduction, and affected body surface area (BSA) reduction in pediatric and adult patients with atopic dermatitis (AD), according to interim data presented in a poster at South Beach Symposium 2024 in Miami Beach, Florida.

In the first in human phase 2 clinical trial of the drug, researchers sought to explore the efficacy of zabalafin hydrogel against both the inflammation and bacterial components of AD in patients with moderate to severe disease.

This trial marks the first known study assessing the efficacy of a drug regarding the bacterial component of the condition. Researchers also looked to assess the safety profile of the drug in patients.

Patients (n=11) involved in the open label phase 2a trial were stratified into 1 of 2 cohorts: a pediatric cohort containing 6 patients between the ages of 2 and 17 years of age and an adult cohort involving 5 patients ranging from 18 to 45 years old. Data from all patients in this interim data began with AD secondarily infected through Skin Infection Rating Scale (SIRS), though the study continued to collect efficacy data.

For an 8-week treatment period, participants (and their parents, if patients were children) were instructed to apply zabalafin on a twice-daily basis. Researchers utilized the vehicle arm of a separate study in order to evaluate the efficacy of zabalafin against the inflammatory component of AD for a 4-week duration.

All participants presented for evaluation on days 8, 15, 29, 43, and 57.

According to the interim data, efficacy of zabalfain was demonstrated in patients regardless of IGA baseline and age grouping.

The trial's primary endpoint of a minimum 2-point or greater IGA score improvement was achieved. Additionally, secondary endpoints including: clear or almost clear IGA score, significant improvement in EASI, and significant improvement in SIRS unique to zabalafin. This is indicative of the drug's demonstrable control of the bacterial microbiome on the skin, which further indicates a capability of controlling bacteria-associated flares and infection.

Regarding itch, reduction was observed with an immediate onset and long-term effect. In 88% of patients, a body surface area reduction of at least 50% was achieved.

One treatment emergent adverse event was reported, involving mild transient stinging in 3 patients. This was noted during approximately 1 to 2 study visits.

"These interim findings for Zabalafin Hydrogel point to this study drug capability to be an effective treatment of AD, for both the inflammation component of AD and uniquely the bacterial component of AD," according to Spelman et al. "Zabalafin Hydrogel demonstrated effective results in both the PC and AC study populations for itch reduction, AD resolution, bacteria control and BSA reduction. Zabalafin Hydrogel is a promising, unique topical AD product for children and adults with the potential to be used chronically, long-term and continuous."

Final results and data are expected to be reported at the completion of the clinical trial.

Reference

Spelman L, Benson M, Shumack S, Koller N, Pekoe G. First in human phase 2 trial of zabalafin (AB-101): A novel topical drug candidate for mild, moderate and severe atopic dermatitis in children and adults – interim results. Poster presented at: South Beach Symposium 2024; February 8-11, 2024; Miami Beach, FL.