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Alphyn Biologics Initiates Phase 2b Trial of Botanical Drug for Atopic Dermatitis
The investigational botanical zabalafin hydrogel has shown antipruritic, antibacterial, and anti-inflammatory properties, addressing the multifactorial nature of AD.
©Alphyn Biologics
Alphyn Biologics has begun patient dosing in its global CLEAR-AD1 phase 2b clinical trial evaluating zabalafin hydrogel for treatment of atopic dermatitis (AD). The randomized, double-blind, vehicle-controlled study is currently enrolling patients in Australia, with plans to expand to US and European sites later this year, according to the company's April 8 news release.
The investigational agent, derived from the company's proprietary Multi-Target Therapeutics platform, is a complex botanical drug with multiple bioactive compounds. According to the company, zabalafin hydrogel has demonstrated antipruritic, antibacterial, and anti-inflammatory properties in preclinical and early clinical evaluations.
The CLEAR-AD1 phase 2b trial will assess safety, efficacy, and tolerability of the hydrogel in 2 distinct participant cohorts: those with bacterial contribution to AD progression without infection, and those with bacterial contribution progressing to infection. This approach addresses the multifactorial nature of AD pathophysiology, potentially offering advantages over current therapies that target isolated aspects of the disease process.
In previously completed phase 2a trials, the company reports that zabalafin hydrogel met all primary and secondary endpoints, showing improvements in pruritus, quality of life, inflammation, and bacterial control. The topical agent was associated with control of bacteria-associated and other AD flares, and clearance of skin where bacteria had progressed AD to infection stage, according to Alphyn. Safety and tolerability profiles were described as favorable.
The US FDA cleared the investigational new drug application for zabalafin hydrogel in February 2025. Results from the CLEAR-AD1 trial may provide further evidence regarding the botanical compound's potential role in management of AD, particularly for patients requiring long-term management options.
Atopic dermatitis affects an estimated 15% to 20% of children and 1% to 3% of adults worldwide.2 Current topical therapies target inflammation or skin barrier dysfunction, but the role of bacterial colonization — particularly Staphylococcus aureus — in disease exacerbations remains a therapeutic challenge.3
Findings from the company's Phase 2a studies were recently published in the Journal of Drugs in Dermatology, presenting preliminary efficacy and safety data to the dermatology community. As with all investigational agents, clinicians should await peer-reviewed results from larger controlled trials before drawing conclusions about therapeutic value or clinical applicability, the company cautioned.
"With the unique properties of our multi-target therapeutic platform, zabalafin hydrogel has the potential to overcome the limitations of current therapeutics and to offer patients a safe, effective therapy for worry-free, long-term continuous use," Alphyn CEO Neal Koller, said in the statement.
