Alphyn Expands Pipeline with Phase 2 Trial of Zabalafin Hydrogel for Molluscum Contagiosum

Alphyn Biologics has announced the dosing of the first patients in a phase 2 clinical trial evaluating topical Zabalafin Hydrogel for the treatment of molluscum contagiosum, marking an important expansion of the company’s dermatology pipeline and the second clinical program derived from its proprietary Zabalafin Platform.¹ The study represents a notable development in an area of pediatric dermatology with persistent unmet need, where existing therapies are often limited by pain, tolerability issues, or incomplete efficacy.

The newly initiated phase 2 study is a randomized, double-blind, placebo-controlled trial that will enroll 54 patients aged 6 months and older across sites in Australia and Latin America. Participants will receive either Zabalafin Hydrogel or placebo, defined as the hydrogel vehicle without the active compound, for a 16-week treatment period, followed by a final assessment 2 weeks later. The primary endpoint is elimination of at least 75% of molluscum lesions.

The Zabalafin Platform

Zabalafin Hydrogel is derived from Alphyn’s proprietary Zabalafin Platform, a natural, plant-based technology composed of multiple bioactive compounds designed to exert complementary mechanisms of action. According to the company, this multi-target approach is intended to address several disease drivers simultaneously. In the case of molluscum contagiosum, Zabalafin Hydrogel is designed not only to directly target the virus itself but also to reduce itch and inflammation and, in patients with associated molluscum dermatitis or secondary infection, to help mitigate these additional contributors to disease burden. This contrasts with many existing therapies that primarily focus on lesion destruction or symptomatic relief, leaving other aspects of the disease to be managed indirectly by host immune responses.

Importantly, Zabalafin Hydrogel for molluscum contagiosum has advanced directly into phase 2 development, supported by an established safety profile of the Zabalafin Platform from prior studies. The same topical formulation is also being developed for atopic dermatitis, where it is designed to target immuno-inflammatory pathways, pruritus, bacterial colonization, and xerosis.² The shared platform underscores Alphyn’s strategy of leveraging a single multi-target therapeutic backbone across multiple dermatologic indications characterized by complex, interconnected pathophysiology.

"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."¹

Understanding Molluscum Contagiosum

Molluscum contagiosum is a common, highly contagious viral skin infection that predominantly affects children, though it can occur in adults and immunocompromised patients. Clinically, the disease is characterized by small, dome-shaped papules that can become inflamed, pruritic, and cosmetically distressing. Beyond the visible lesions, many patients experience secondary complications, including molluscum-associated dermatitis, excoriation from scratching, and superimposed bacterial infection with associated pain. While the condition is often self-limited, spontaneous resolution may take months to years, during which time lesions can spread within the individual and to close contacts, creating a significant psychosocial and public health burden.

Current treatment options for molluscum contagiosum are suboptimal for many patients, particularly young children. Office-based procedures such as curettage, cautery, and cryotherapy are effective in lesion destruction but are often painful, anxiety-provoking, and poorly tolerated in pediatric populations. Although 2 therapies have recently received US Food and Drug Administration approval, there remains strong interest in additional topical options that are safe, pain-free, and easy to administer at home. Thus, a topical agent that could directly target the virus while also addressing inflammation and pruritus would represent a meaningful advance.

References

1. First Patients Dosed in Alphyn Biologics' Phase 2 Trial of First-in-Class Topical Therapeutic for Molluscum Contagiosum. News release. PR Newswire. Published February 18, 2026. Accessed February 19, 2026. https://www.prnewswire.com/news-releases/first-patients-dosed-in-alphyn-biologics-phase-2-trial-of-first-in-class-topical-therapeutic-for-molluscum-contagiosum-302691290.html

2. Alphyn announces first patient dosed in CLEAR-AD1 global phase 2b clinical trial program of zabalafin hydrogel for atopic dermatitis. News release. PR Newswire. Published April 8, 2025. Accessed February 19, 2026. https://www.prnewswire.com/news-releases/alphyn-announces-first-patient-dosed-in-clear-ad1-global-phase-2b-clinical-trial-program-of-zabalafin-hydrogel-for-atopic-dermatitis-302422539.html