Alphyn Announces First Patient Dosed in CLEAR-AD1 Global Phase 2b Clinical Trial Program of Zabalafin Hydrogel for Atopic Dermatitis

First topical therapeutic to directly treat the immuno-inflammatory and bacterial causes of the disease at all stages, from AD onset through infection

ANNAPOLIS, Md., April 8, 2025 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the first patient has been dosed in its CLEAR-AD1 Phase 2b clinical trial of Zabalafin Hydrogel in Australia. The trial will evaluate the safety, efficacy, and tolerability of Zabalafin Hydrogel in patients with mild and moderate atopic dermatitis (AD) and directly treat the immuno-inflammatory and bacterial causes of the disease at all stages, from AD onset to infection. 

Zabalafin Hydrogel offers the potential to be the first singular comprehensive approach to uniquely and effectively directly control the itch, stop the immuno-inflammatory cascade, and eliminate the bacterial cause and progression of AD. The CLEAR-AD1 trial is a randomized, double-blinded, vehicle-controlled study enrolling patients at two different stages of AD disease progression – one in which bacteria have contributed to the progression of AD but not yet to the infection stage, and the other in which bacteria have contributed to the progression of AD to the infection stage.

"The initiation of patient dosing in our CLEAR-AD1 Phase 2b clinical trial is another significant milestone for Alphyn, as we strive to bring to market our single comprehensive treatment for patients who suffer from this often-devastating chronic disease," said Alphyn CEO Neal Koller. "With the unique properties of our multi-target therapeutic platform, Zabalafin Hydrogel has the potential to overcome the limitations of current therapeutics and to offer patients a safe, effective therapy for worry-free, long-term continuous use."

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. The therapeutic is derived from the company's Zabalafin Platform with its Multi-Target Therapeutics.

Alphyn secured clearance from the U.S. Food and Drug Administration of its investigational new drug application for Zabalafin Hydrogel in February and is seeking regulatory approval to begin clinical trials in Europe. The company anticipates initiating clinical trials in the U.S. and in Europe later this year.

Alphyn completed two AD Phase 2a clinical trials that 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 AD skin where the bacteria progressed AD to infection stage. In addition to its strong efficacy results, Zabalafin Hydrogel demonstrated excellent safety, side-effect, and patient tolerability.

In November, Alphyn announced the first peer-reviewed article published by leading dermatologists authors in the Journal of Drugs in Dermatology, highlighting the strong efficacy and patient tolerability profile and potential of Zabalafin Hydrogel to treat all the problems of AD.

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.