#United States #Orlando #Atopic Dermatitis #Zabalafin Hydrogel #Alphyn Biologics

Alphyn's Pioneering Zabalafin Hydrogel for Atopic Dermatitis

At the recent American Academy of Dermatology (AAD) annual meeting, Alphyn Biologics showcased their novel treatment, Zabalafin Hydrogel. This innovative topical therapy represents a significant advancement in the management of atopic dermatitis (AD), effectively addressing the itch, bacterial involvement, and immuno-inflammatory aspects that characterize the condition.

During the presentation, results from their Phase 2a clinical program were discussed, highlighting the hydrogel's potential for offering a singular, comprehensive solution for patients with varying stages of AD.

Clinical Successes from Phase 2a Trials

The clinical trial featured two distinct patient cohorts: Cohort A consisted of individuals experiencing mild to moderate AD without active infections, while Cohort B included those whose condition had progressed to the infection stage due to bacterial involvement. The results were compelling, indicating that Zabalafin Hydrogel provided substantial relief across multiple symptoms.

Cohort A Findings

Cohort A's results stemmed from a robust double-blind, randomized, vehicle-controlled trial involving patients aged between 2 and 66. After just four weeks of administering the hydrogel twice daily, participants exhibited a marked reduction in itch levels and overall AD symptoms compared to the control group. Importantly, the treatment was well-tolerated, with no significant adverse effects reported, solidifying its safety profile during this initial phase.

Cohort B Findings

In Cohort B, participants with AD infections showed impressive improvements after receiving the hydrogel. Within this subgroup, significant itch reduction was noted: 68% of patients reported a decrease of over four points on the Pruritus Numerical Rating Scale (NRS) by the end of treatment. Additionally, the quality of life for patients improved dramatically, as evidenced by a score increase of more than six points on the Patient Oriented Eczema Measurement scale (POEM) in 89% of subjects. Furthermore, an investigator assessment indicated that 50% of patients reached a clear/almost clear status concerning inflammation within 12 weeks. The hydrogel also demonstrated remarkable efficacy against bacterial infections, including that caused by methicillin-resistant Staphylococcus aureus (MRSA), with 84% of infected patients achieving clearance.

A Promising Future for Zabalafin Hydrogel

Alphyn's CEO, Neal Koller, expressed enthusiasm regarding the findings: "The collective data from the Phase 2a trial showcases Zabalafin Hydrogel’s capacity to address the existing gaps in AD therapies, paving the way for a single, reliable treatment option for long-term use. We are eager to initiate our global Phase 2b trials, pushing towards the goal of establishing Multi-Target Therapeutics for chronic and serious skin conditions, beginning with AD."

Zabalafin Hydrogel is a unique, first-in-class therapeutic derived from a botanical source, incorporating diverse bioactive compounds to combat itchiness, provide antibacterial benefits, and alleviate inflammation. Its development heralds a new chapter in AD management, promising a well-rounded treatment that tackles the multifaceted nature of the disease.

About Alphyn Biologics

Founded in 2020, Alphyn Biologics is dedicated to innovating treatments for severe skin conditions using their proprietary Zabalafin Platform. Their work emphasizes the development of Multi-Target Therapeutics, which may revolutionize how chronic skin diseases are treated, ensuring safer and more effective options for patients. Headquartered in Annapolis, Maryland, with operational footprints in Cincinnati, Ohio, and international reach through subsidiaries in Australia and Austria, Alphyn continues to make strides in the dermatological field. The recent presentation at the AAD reinforces their commitment to enhancing the quality of life for individuals suffering from atopic dermatitis.