Alphyn Completes Enrollment in Phase 2 Trial of Topical Therapy for Molluscum Contagiosum

Company's patented multi-target therapeutics^® platform establishes a new class of patient-friendly treatments

ANNAPOLIS, Md., March 24, 2026 /PRNewswire/ -- Alphyn Biologics, Inc., a clinical-stage dermatology company developing the first Multi-Target Therapeutics^® drug platform, today announced completion of enrollment in its Phase 2 clinical trial of topical Zabalafin Hydrogel (ZH) for the treatment of molluscum contagiosum (MC), an unsightly and highly contagious skin disease predominantly found in children.

"Our Phase 2 trial of Zabalafin Hydrogel for molluscum contagiosum completed enrollment significantly ahead of schedule, underscoring the serious need for a patient-friendly, effective treatment for this highly prevalent and very stubborn disease," said Alphyn CEO Neal Koller. "Many children with molluscum contagiosum must endure not only the symptoms, but also the treatments, which are painful, often intolerable, and cause scarring. Zabalafin Hydrogel aims to be the first drug to directly kill the virus and restore the skin in an effective, skin-sensitive, and gentle way."

The randomized, double-blind, placebo-controlled trial enrolled 54 patients aged 6 months and older in Australia. Patients receive ZH or placebo (the hydrogel vehicle that delivers zabalafin) for 16 weeks and return for a final visit two weeks later. The primary endpoint is the elimination of at least 75 percent of MC lesions in a patient. Alphyn expects to report topline results in the third quarter of 2026.

MC causes small, raised bumps that are unsightly, embarrassing, and inflamed. The MC lesions spread easily and are often incessantly pruritic (itchy). Many sufferers experience dermatitis (molluscum rash), which may lead to a painful bacterial infection. Current office surgical procedures, such as curettage, cautery, and cryotherapy, can be painful and difficult for children to tolerate. While two new FDA-approved drugs are now available, the need for easy-to-use, effective, and pain-free therapeutic options remains.

This is Alphyn's second clinical program based on the company's proprietary Zabalafin Platform for generating Multi-Target Therapeutics - a new class of drugs. ZH for MC is in development to target the multiple problems of MC, including directly killing the virus in a skin-sensitive manner, as well as the itch, inflammation, and, in certain patients, dermatitis and bacterial infection. Similarly, ZH for atopic dermatitis (AD) targets the key, interconnected drivers of AD. Both drug indications are expected to complete their Phase 2 clinical trial programs in summer 2026.

Alphyn's Zabalafin Drug Platform is a natural plant-based technology supporting a robust pipeline of therapeutics with potential advantages in efficacy, safety, side effect, patient tolerability, and regulatory marketing authorization advantages. Alphyn's therapeutic candidates were able to advance directly to Phase 2 clinical trials based on the Platform's established safety profile.

The Zabalafin Drug Platform is differentiated by its unique ability to directly target multiple disease drivers through its multiple bioactive compounds with multiple mechanisms of action. In contrast, most existing drugs pose only one bioactive with only one mechanism of action, directly addressing only one disease symptom.

Alphyn will be exhibiting at Booth 2555 at the American Academy of Dermatology annual meeting March 27-29 in Denver. Please visit us to learn more about our platform and dermatology programs.

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, and 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