The trial meets all primary and secondary endpoints in the pediatric population from 2 years of age
ANNAPOLIS, Md. and MÁLAGA, Spain, May 4, 2023/PRNewswire/ — Alphyn Biologics, a clinical-stage dermatology company developing world-class multi-target therapies, today announced at the 22nd European Society for Pediatric Dermatology Congress ( ESPD) positive results from the pediatric population enrolled in its phase 2a clinical trial of AB-101a, a new topical candidate for mild to moderate atopic dermatitis (AD). The trial, the first of its kind, met all primary and secondary efficacy endpoints in the pediatric population from 2 years of age, with minimal safety and side effects.
AB-101a is being developed to uniquely treat the immune and bacterial components of AD, with a safety profile that supports its continued long-term use. In January, Alphyn reported positive results from the first cohort of his phase 2a trial. A second cohort of AD patients is underway evaluating the impact of AB-101a on bacterial complications of AD.
“We are very pleased with the pediatric results announced today,” said Alphyn CEO Neal Koller. “The improvements these children experienced in disease severity and symptoms are particularly noteworthy. AD can be a lifelong chronic disease, and long-term continued use options are needed.”
The Phase 2a double-blind randomized trial is evaluating the safety and efficacy of AB-101a, with the first cohort of 41 patients ranging in age from 2 years to adults, compared to a control vehicle. Pediatric data from the first cohort published today show that all primary efficacy endpoints were met, including a reduction in disease severity as indicated by the Investigator’s Global Assessment (IGA) score and some side effects and minimum security. Secondary endpoints of Eczema Area and Severity Index (EASI) score improvement, immediate and long-term reduction of itch, and body surface area (BSA) improvement were also achieved in all pediatric age groups. Pediatric outcomes are detailed in a poster (P198) on ESPD.
Alphyn is developing AB-101a as the first AD therapy to address both the immune system component and the bacterial complications of the disease, including those commonly associated with Staph (Staphylococcus aureus) and methicillin-resistant Staph (MRSA). Based on the positive trial results, Alphyn plans to initiate a multinational Phase 2b trial with centers in the United States, Europe, Canada, and Australia.
ABOUT ALPHYN BIOLOGICS
Alphyn Biologics is a clinical-stage dermatology company developing world-class, multi-targeted therapies for serious and prevalent skin diseases based on its AB-101 platform. Its lead product candidate, AB-101a, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema. AB-101a has demonstrated a strong safety profile and is being developed to uniquely target the immune system and bacterial components of AD, making it ideal for treating AD and AD with secondary infection. Alphyn’s AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust portfolio of dermatology therapeutics that have potential safety, efficacy, and regulatory marketing clearance advantages. Alphyn is headquartered in Annapolis, Maryland, and Cincinnati, Ohio, with a wholly-owned Australian subsidiary. The company went live in 2020 and has raised approximately $6.9 million.
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