First Patients Dosed in Alphyn Biologics' Phase 2 Trial of First-in-Class Topical Therapeutic for Molluscum Contagiosum

New program expands pipeline derived from Alphyn's proprietary multi-target drug platform

ANNAPOLIS, Md., Feb. 18, 2026 /PRNewswire/ -- Alphyn Biologics, Inc., a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, today announced dosing of the first patients in its Phase 2 clinical trial of topical Zabalafin Hydrogel (ZH) for the treatment of the topical viral disease Molluscum Contagiosum (MC), a highly contagious skin infection common in childhood. This is Alphyn's second clinical program based on the company's unique and proprietary Zabalafin Platform for generating Multi-Target Therapeutics.

"The launch of our clinical program for MC represents another significant milestone for Alphyn and further validates our Zabalafin Platform," said Alphyn CEO Neal Koller. "Zabalafin Hydrogel for MC has the potential to fill a critical gap in treatment by directly targeting the multiple problems of this disease – including, uniquely, the direct elimination of the virus itself with a skin-friendly, well-tolerated topical formulation – plus targeting MC's itch, inflammation and, in certain patients, dermatitis and bacterial infection with its associated pain."

The randomized, double-blind, placebo-controlled trial will enroll 54 patients ages 6 months and older in Australia and Latin America. Patients will receive ZH or placebo (the hydrogel vehicle that delivers zabalafin) for the first 16 weeks and return for a final visit two weeks later. The primary endpoint for the trial is the elimination of at least 75 percent of the MC lesions.

MC causes small, raised bumps that are unsightly, embarrassing, and inflamed. They are highly contagious and spread easily on the body, as well as incessantly pruritic (itchy). Many sufferers experience dermatitis (molluscum rash) as well as the potential for a bacterial infection and its associated pain. A critical unmet need exists for a topical treatment for MC that is safe, pain-free, gentle and effective. Current office surgical procedures such as curettage, cautery and cryotherapy can be painful and difficult for children to tolerate. While there are two new FDA approved treatments for MC, new safe, effective and pain-free options for MC treatment are desirable. ZH has the potential to be the first direct antiviral drug that is safe, gentle and effective, and therefore the first real antiviral treatment option for the millions of children afflicted with this disease.

Like ZH for atopic dermatitis, ZH for MC has advanced directly to the Phase 2 clinical trial, supported by the established safety profile of the Zabalafin Drug Platform. ZH for both indications is differentiated by its unique ability to directly target multiple disease drivers. Existing therapies directly treat only one symptom of the disease, leaving the body to later fight the others. Alphyn's Zabalafin Drug Platform is a natural plant-based technology comprising multiple bioactive compounds with multiple mechanisms of action to support treatment of an individual disease in multiple ways, with improved efficacy. Alphyn's Platform supports a robust pipeline of therapeutics that have potential efficacy, safety, side effect, patient tolerability, and regulatory marketing authorization advantages.

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, and molluscum contagiosum (MC), an unsightly, pruritic (itchy), and highly contagious skin infection predominantly in children.

Zabalafin Hydrogel is unique in its ability to directly treat all the interconnected problems of both AD and MC. For AD, Zabalafin Hydrogel directly treats the immuno-inflammatory component of the disease, directly treats pruritus (itch), directly treats the bacterial component of AD, and directly treats xerosis (dry skin). For MC, Zabalafin directly targets the virus itself in a gentle skin friendly manner, directly treats itch, directly treats inflammation and, in many sufferers, directly treats dermatitis (molluscum rash) and the added problem of bacterial infection with its associated pain.

Alphyn's Zabalafin Platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to support treatment of an individual disease in multiple ways, for anticipated improved 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. 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 $34 million.

SOURCE Alphyn Biologics, Inc.