Alphyn Completes Enrollment in CLEAR-AD1 Global Phase 2b Clinical Trial of Novel Topical for Atopic Dermatitis

Multi-target therapeutic aims to treat all key and interconnected problems of atopic dermatitis

ANNAPOLIS, Md., March 11, 2026 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing the first Multi-Target Therapeutics^® drug platform, announced today that it has completed enrollment in its CLEAR-AD1 Phase 2b clinical trial of Zabalafin Hydrogel, a first-in-class topical therapeutic for the treatment of mild and moderate atopic dermatitis (AD) derived from the company's proprietary Multi-Target Therapeutic Drug Platform.

"A great need continues to exist for a patient-friendly therapeutic that directly and immediately treats each of AD's four key interconnected problems - itch, the bacteria mechanisms that contribute to the onset and symptoms of the disease, the immuno-inflammatory cause, and dry skin - and is suitable for continuous, long-term use. This is the differentiating promise of our Zabalafin Hydrogel," said Alphyn CEO Neal Koller. "Enrollment completion marks another step toward bringing to doctors and patients the first multi-target AD treatment that addresses the entire spectrum of disease problems. As a natural, non-steroidal topical drug, we believe Zabalafin Hydrogel will fill the critical gap in AD treatments."

AD is a chronic disease, reported to be the largest dermatology disease in the world. The CLEAR-AD1 trial is a randomized, double-blind, vehicle-controlled clinical trial enrolling patients at two different stages of AD disease – AD disease at the bacterial colonization stage, where bacteria have contributed to the onset and progression of AD but not to where the AD has progressed to the bacterial infection stage, and the other in which bacteria have led to the progression of the disease to the bacterial infection stage. The multi-center 18-week trial enrolled 129 patients, with first-in-human use starting at ages 2 and older using standard AD clinical trial endpoints and, uniquely, endpoints that measure success against the bacterial cause of the disease. Alphyn expects to release topline results by mid-year 2026.

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, anti-xerosis (dry skin) and anti-inflammatory activity. The topical therapeutic is also being studied in a Phase 2 clinical trial for the treatment of molluscum contagiosum, a persistent viral skin disease common in childhood.

ABOUT ALPHYN BIOLOGICS

Alphyn Biologics, Inc. is a clinical-stage dermatology company developing its patented Zabalafin Platform, the first Multi-Target Therapeutics^® (MTT^®)drug platform for severe and prevalent skin diseases. The company's lead product candidate, Zabalafin Hydrogel, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema. It has a second clinical-stage MTT platform candidate for molluscum contagiosum (MC), an unsightly, pruritic (itchy), and highly contagious skin infection predominantly found in children.

Alphyn's Zabalafin Platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to support treatment of a complex individual disease in multiple ways, for anticipated improvement in efficacy, and to provide a robust pipeline of dermatologic therapeutics that have potential advantages in efficacy, safety, side effect, patient tolerability, and regulatory marketing authorization. For both AD and MC, Alphyn's drug candidates target directly each of the four key problems of these diseases. 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 $35 million.

SOURCE Alphyn Biologics