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News

Article

April 8, 2025

Alphyn Doses First Patient in Phase 2b Trial for Zabalafin Hydrogel

Author(s):

Key Takeaways

Zabalafin hydrogel targets multiple aspects of atopic dermatitis, including inflammation, itch, and bacterial involvement, offering a holistic treatment approach.
Phase 2a trials demonstrated significant improvements in itch reduction, inflammation resolution, and bacterial control, with a favorable safety profile.
Alphyn Biologics is expanding its clinical development globally, with US FDA clearance and European regulatory approvals in progress.
The CLEAR-AD1 trial stratifies patients based on disease stage, focusing on bacterial involvement and infection in atopic dermatitis.

Alphyn Biologics has dosed the first patient in a global phase 2b trial of zabalafin hydrogel for mild to moderate atopic dermatitis.

A child scratching their arm, showing symptoms of atopic dermatitis

Image Credit: © Evgeniya Primavera - stock.adobe.com

Alphyn Biologics announced today that the first patient has been dosed in its global phase 2b clinical trial of zabalafin hydrogel for patients with mild to moderate atopic dermatitis (AD).¹

The CLEAR-AD1 clinical trial is a global, multicenter, randomized, double-blind, vehicle-controlled study launched in Australia and is designed to evaluate the safety, efficacy, and tolerability of zabalafin hydrogel in this patient population.

In this trial, patients will be stratified into into 1 of 2 cohorts representing distinct disease stages of AD, including those in whom bacterial involvement has contributed to AD progression but not led to infection, and those where infection is already established.

A Multi-Targeted Strategy

Zabalafin hydrogel is an investigational, first-in-class, botanical drug developed from Alphyn’s proprietary Multi-Target Therapeutics platform. The formulation integrates multiple naturally derived bioactive compounds that exert anti-inflammatory, anti-pruritic, and antibacterial effects to simultaneously disrupt the inflammatory cascade, reduce itch, and control bacterial involvement.¹

According to Alphyn, while conventional therapies tend to target isolated aspects of AD such as inflammation or itch, zabalafin aims to treat the disease holistically and continuously. This may offer particular benefit to patients with chronic, relapsing AD who often need to cycle through multiple treatments due to safety concerns, antibiotic resistance, or loss of efficacy.²

Phase 2a Results Set the Stage

The initiation of the CLEAR-AD1 study follows Alphyn’s successful completion of 2 phase 2a trials, in which zabalafin hydrogel demonstrated clinically meaningful improvements across several key domains.³

The hydrogel significantly reduced itch, improved patient-reported quality of life, resolved inflammation, and controlled flares associated with bacterial colonization and infection, all with a favorable safety and tolerability profile. The treatment was well tolerated, with no serious adverse events reported.

Read more from Dermatology Times.

These earlier results were recently highlighted in a peer-reviewed publication in the Journal of Drugs in Dermatology by a panel of dermatology researchers.⁴ The report emphasized zabalafin’s differentiated mechanism of action and potential to simplify AD management by addressing itch, inflammation, and bacterial triggers in a single formulation.

Global Development Strategy

While the current study begins in Australia, Alphyn is actively expanding its clinical development footprint. The US FDA granted clearance for the company’s Investigational New Drug application in February 2025, paving the way for US-based trials.⁵ Additionally, Alphyn is in the process of securing regulatory approvals in Europe, with trial launches expected later this year.

"The initiation of patient dosing in our CLEAR-AD1 phase 2b clinical trial is another significant milestone for Alphyn, as we strive to bring to market our single comprehensive treatment for patients who suffer from this often-devastating chronic disease," said Alphyn CEO Neal Koller in a news release.¹ "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."

References