Zabalafin Hydrogel 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. and VIENNA, May 12, 2025 /PRNewswire/ — Alphyn GmbH, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, announced today that it has initiated its CLEAR-AD1 Phase 2b clinical trial of Zabalafin Hydrogel in Australia and has dosed the first 8 patients. The company anticipates expanding the trial to sites in Europe and the United States later this year. 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.
“We are making significant progress in patient enrollment in our CLEAR-AD1 Phase 2b global clinical trial program, which is a testament to the great patient need for a new therapeutic that comprehensively and immediately treats all the key problems of AD,” said Alphyn CEO Neal Koller. “We look forward to expanding our clinical trial program in Europe and the United States later this year and the possibility of bringing to patients the first AD drug that is worry-free and ideally suited for long-term and continuous use, and that overcomes current drugs’ efficacy and safety limitations.”
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.
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 AD’s pruritus (itch), directly treating the bacterial cause of AD, 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 $20.3 million.
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