Alphyn Biologics Doses First Patients in Phase 2 Trial for Molluscum Contagiosum Treatment

Alphyn Biologics, Inc., a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, announced on February 18, 2026, dosing of the first patients in its Phase 2 clinical trial of topical Zabalafin Hydrogel (ZH) for the treatment of 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 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.

The CEO stated that 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.

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.

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.

Alphyn Biologics 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.