Alphyn Poster at American Academy of Dermatology Annual Meeting Highlights Potential of Zabalafin Hydrogel as Singular, Comprehensive Treatment for Atopic Dermatitis

Phase 2a clinical program demonstrates safety and efficacy for all endpoints in AD with and without secondary infection

ANNAPOLIS, Md. and ORLANDO, Fla., March 10, 2025 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today a poster presentation on Zabalafin Hydrogel at the American Academy of Dermatology (AAD) annual meeting demonstrating the topical therapeutic's potential as a singular comprehensive approach to effectively managing the itch, bacterial cause, and immuno-inflammatory cause of atopic dermatitis (AD) and its progression. The poster detailed results from a first-of-its-kind Phase 2a clinical program evaluating Zabalafin Hydrogel in patients at two different stages of AD disease progression, one where bacteria have contributed to the progression of AD but not yet to the infection stage and one where bacteria have contributed to the progression of AD to the infection stage.

The Phase 2a clinical trial program met all primary and secondary endpoints, demonstrating Zabalafin Hydrogel significantly improved pruritus (itch), quality of life, inflammation, as well as control of bacteria-associated and other AD flares, and clearance of infected AD skin. In addition to its strong efficacy results, Zabalafin Hydrogel demonstrated excellent safety, side-effect profile, and patient tolerability.

"The results for the entire Phase 2a clinical program, presented together for the first time at AAD, illustrate the potential of Zabalafin Hydrogel to overcome the shortcomings of current AD therapeutics to offer a single, comprehensive AD treatment that is suitable for long-term, worry-free, continuous use," said Alphyn CEO Neal Koller. "We're excited to begin our global Phase 2b clinical trial program shortly, to advance our goal of developing new, multi-target therapeutics for chronic, serious, and prevalent diseases, beginning with AD."

The Phase 2a clinical trial program included two cohorts of patients with mild and moderate AD. Cohort A, where bacteria have contributed to the progression of AD but not yet to the infection stage, was a double-blind, randomized, vehicle-controlled study of patients ages 2 to 66 with mild or moderate AD. Results showed Zabalafin Hydrogel dosed twice-daily was significantly better than the vehicle after 4 weeks and reduced each of the problems of AD with no safety concerns.

Cohort B, where bacteria have contributed to the progression of AD to the infection stage, was an open-label study of patients ages 3 to 63 with mild and moderate AD. Eleven patients completed 8 weeks of twice-daily treatment and 8 completed 12 weeks of treatment. Results showed strong improvement in itch with Pruritus Numerical Rating Scale (NRS) reduction of greater than 4 in 68 percent of patients by end of treatment, and excellent quality of life improvement, as shown in the Patient Oriented Eczema Measurement scale (POEM) of greater than 6 in 89 percent of patients. Clinically relevant reduction in inflammation was demonstrated using Investigator Global Assessment, or IGA, with 50 percent of patients achieving an IGA of clear/almost clear and greater than 2 improvement at 12 weeks. Additional demonstration of inflammation reduction was seen using the Eczema Area and Severity Index (EASI) with 79 percent of patients achieving an EASI50 score (AD improvement of at least 50 percent), 47 percent achieving an EASI75 score (AD improvement of at least 75 percent), and 10 percent achieving an EASI100 score (AD improvement of 100 percent) at 12 weeks. Success treating the most difficult AD disease condition of bacteria-caused AD infection was demonstrated where 84 percent of patients had their AD infection cleared, and 100 percent had their AD infection caused by drug-resistant MRSA (methicillin-resistant Staphylococcus aureus) cleared. Only one adverse event was reported, which was mild transient stinging that did not interrupt treatment.

Zabalafin Hydrogel is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic (anti-itch), antibacterial, and anti-inflammatory activity. It is derived from the company's Zabalafin platform, a platform for first-in-class Multi-Target Therapeutics^®, that provides a deep and rich new drug candidate pipeline.

ABOUT ALPHYN BIOLOGICS

Alphyn Biologics, Inc. is a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^® for severe and prevalent skin diseases based on its Zabalafin Platform. Its lead product candidate, Zabalafin Hydrogel, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema.

Zabalafin Hydrogel has demonstrated strong efficacy and safety in Phase 2a clinical trials, suggesting it has the potential to be the first comprehensive AD treatment that is worry-free for long-term, continuous use. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD's pruritus (itch), and directly treating the immuno-inflammatory cause of the disease.

Alphyn's Zabalafin Platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential efficacy, safety, side effect, patient tolerability, and regulatory marketing authorization advantages. Alphyn is based in Annapolis, Maryland, and Cincinnati, Ohio, and has wholly owned subsidiaries in Australia and Austria. The company became operational in 2020 and has raised approximately $17 million.

SOURCE Alphyn Biologics, Inc.