Positive Phase 2a Trial Outcomes for Zabalafin Hydrogel in Atopic Dermatitis

In a recent announcement, Alphyn, a dermatology firm specializing in innovative Multi-Target Therapeutics®, revealed the successful outcomes of the second group in their Phase 2a clinical study. The study focused on the efficacy and safety of zabalafin hydrogel (AB-101a) for patients suffering from atopic dermatitis (AD), particularly those with infected skin lesions. The results were promising, with the hydrogel meeting all pre-specified safety and efficacy goals.
The clinical trial, which included participants aged between 2 and 45, showcased substantial improvements in itch intensity, patient-reported quality of life, and inflammation. Notably, the treatment was associated with minimal adverse effects and was well-tolerated by the patients. The study's endpoints encompassed a range of assessments, from itch reduction and life quality improvements to safety and tolerability evaluations, as well as specific scales like the Skin Infection Rating Scale (SIRS), body surface area (BSA) reduction, Investigator Global Assessment (IGA), and Eczema Area and Severity Index (EASI) score enhancements.
The findings indicated that nearly 70% of the participants noted a significant reduction in itch levels, while 90% experienced an improvement in life quality as measured by the Patient Oriented Eczema Measure (POEM) scale. The SIRS scores, which reflect skin infection control, decreased steadily in all patients, with over 70% achieving a notable improvement of six or more points. Additionally, 84% of those with infected AD skin saw complete clearance by the end of the treatment period. The hydrogel's antibacterial efficacy was found to be on par with the standard Vancomycin treatment, even eliminating one instance of bacteria resistant to the latter.
In terms of EASI scores, 84% of the patients reached an EASI50 score, indicating at least a 50% improvement in AD symptoms, while 50% achieved an EASI75 score and 10% reached an EASI100 score. The study also highlighted that half of the patients showed a marked reduction in AD's inflammatory component, as evidenced by a two-point or greater improvement in the IGA score. Moreover, 90% of the patients had a one-point reduction in IGA score by the end of treatment, indicating nearly universal assistance and symptom improvement.
Dr. Stephen Shumack, the principal investigator of the trial, highlighted the limitations of current AD treatments, which primarily address the inflammatory aspect of the disease and come with side effects that may hinder long-term use. The study suggests that zabalafin hydrogel could offer a solution by also targeting itch and bacterial components associated with AD flares, without significant side effects, thus providing a potentially safer long-term treatment option.
Alphyn's CEO, Neal Koller, expressed enthusiasm about the data, which, combined with the first cohort's results, positions zabalafin hydrogel as a potential frontrunner in AD treatment. With its multifaceted action, the hydrogel could become the first comprehensive treatment directly addressing all disease components. Alphyn is now gearing up for a global Phase 2b clinical trial, slated for the latter half of 2024, concurrent with their Series B financing efforts.
Zabalafin hydrogel is a groundbreaking botanical drug derived from Alphyn's Zabalafin Platform, which contains multiple bioactive compounds. It offers a multi-pronged approach to treating AD, including anti-pruritic, antibacterial, and anti-inflammatory properties. Alphyn Biologics, established in 2020, is focused on developing cutting-edge dermatological therapeutics for severe and widespread skin conditions, with zabalafin hydrogel as their leading candidate for treating AD, both with and without skin infections.