Zabalafin Hydrogel Significantly Improves Itch in Phase 2a Trial for AD

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Alphyn Biologics recently announced new positive data from its second cohort of its phase 2a clinical trial evaluating the safety and efficacy of zabalafin hydrogel (AB-101a) in patients with atopic dermatitis (AD) and infected AD skin. Zabalafin met all of its safety and efficacy end points and demonstrated clinically relevant improvements in itch, patient-assessed quality of life indications, inflammation, and safety when compared at baseline. Additionally, there were minimal adverse effects and patients tolerated zabalafin well.

Results from the second cohort of the phase 2a trial are as follows:

• 68% of patients experienced an itch score improvement of at least 4 using the Numerical Rating Scale at the blended end of treatment (EoT)
• 90% of patients had a Patient Oriented Eczema Measure scale quality-of-life improvement of at least 6 at EoT
• 74% of patients achieved a Skin Infection Rating Scale (SIRS) score improvement of 6 or more points, equal to an improvement of 62 percent at EoT
• 84% of patients with infected AD skin were cleared at EoT
• 84% of patients achieved an EASI50 score, 50% achieved an EASI75 score, and 10% achieved an EASI100 score at 12 weeks
• 50% of patients experienced a reduction of the inflammation component of AD as indicated by 2 or greater improvement in the IGA score and IGA score achieving clear or almost clear at 12 weeks
• 90% of patients experienced a 1-point reduction in IGA score at EoT, demonstrating that almost all patients were helped and showed some improvement in their AD

Additionally, all patients demonstrated a steady decrease in SIRS score, demonstrating control of the Staphylococcus aureus bacteria-associated and other AD flares. Itch reduction was demonstrated in immediacy of onset and long-term. Finally, there was only 1 reported treatment-emergent adverse event of mild transient stinging in 1 or 2 study visits for 3 participants.

“There are well-known shortcomings with current atopic dermatitis therapeutics that, while effective, treat only the inflammatory component of the disease, and have side effects and safety warnings that restrict long-term and continuous use,” said Stephen Shumack, MD, principal investigator of the phase 2a trial, in the news release. “This trial suggests that zabalafin hydrogel could address these shortcomings by treating, in addition to AD's inflammatory component, both itch and AD’s bacterial component, which are known to be associated with AD flares. Importantly, zabalafin hydrogel’s minimal side effect profile and excellent patient tolerability, combined with its efficacy, suggest it offers patients a worry-free option for continuous, long-term use.”

Zabalafin hydrogel is a novel, first-in-class complex single-source botanical agent with “multiple bioactive compounds that provides multiple mechanisms of action, including anti-pruritic, antibacterial, and anti-inflammatory activity,” according to Alphyn. Zabalafin hydrogel would be the first AD therapeutic to treat the bacterial complications of AD, specifically Staphylococcus aureus and methicillin-resistant Staphylococcus.

Reference

Alphyn announces positive results from second cohort of phase 2a clinical trial in atopic dermatitis. News release. PR Newswire. March 7, 2024. Accessed March 7, 2024. https://www.prnewswire.com/news-releases/alphyn-announces-positive-results-from-second-cohort-of-phase-2a-clinical-trial-in-atopic-dermatitis-302082303.html