– Alphyn Biologics Presents New Data From a Phase 2a Trial Showing Significant Improvement in Mild to Moderate Atopic Dermatitis
– Statistically significant improvements in IGA (Investigator Global Assessment) and EASI (Eczema Area and Severity Index) scores
– Rapid reduction of itching on the 4th day and sustained reduction of itching
– Reduction of body surface area (BSA) by at least 50%
– Significant improvement of the Skin Infection Rating Scale (SIRS)
ANNAPOLIS, Md., July 13, 2023/PRNewswire/ — Alphyn Biologics, a clinical-stage dermatology company developing world-class Multi-Target Therapeutics® treatments, today announced new data from the first cohort of its Phase 2a clinical trials of AB-101a, a first-in-class topical candidate for the treatment of atopic dermatitis (AD) in children 2 years to adults. Data show significant skin clearance of disease, reduction of itch, and control of AD flare-ups by treating the bacterial skin microbiome with DA.
The randomized, double-blind, vehicle-controlled trial evaluated the safety and efficacy of AB-101a, a topical hydrogel using Alphyn’s proprietary AB-101 multi-target therapeutic platform, in 41 patients from seven centers over four weeks. Randomization resulted in 81% participation of patients with mild AD, a study population in which it is difficult to demonstrate improvement resulting from a therapeutic intervention.
As previously reported, the trial met all primary and secondary endpoints with minimal safety and side effects. New data released in a poster at the World Congress of Dermatology in Singapore showed the following:
“Overall, these findings are clear and compelling,” said Neal Koller, CEO. “While we are especially excited about the statistically significant improvements in IGA and EASI scores, which were remarkably achieved in an overwhelmingly mild population of just 41 patients and in just four weeks, we are also very encouraged by the rapid reduction in itch and the unique aspects of skin microbiome control to manage AD flare-ups that are primarily caused by bacteria.
AB-101a is being studied in two cohorts in a Phase 2a trial program. The second cohort of the trial is an open-label study evaluating patients with mild, moderate, and severe AD with secondary infection and control of the AD skin bacterial microbiome. The trial has completed enrollment and is expected to conclude with 20 patients. Interim results from the second cohort will be presented in a poster at the Society for Pediatric Dermatology annual meeting, July 13-16.
Alphyn is developing AB-101a as the first AD therapeutic drug to treat the immune system component and bacterial complications of the disease, including those commonly associated with staphylococcus (Staphylococcus aureus) and methicillin-resistant staphylococcus (MRSA). ). AB-101a is a first-in-class novel single-origin complex botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-inflammatory, antipruritic, and antibacterial activity, indicating that AB-101a should be effective in the DA. Based on the positive trial results, Alphyn intends to initiate a multinational Phase 2b trial with sites in the United States, Europe, Canada, and Australia, and is raising a Series B to fund this program.
ABOUT ALPHYN BIOLOGICS Alphyn Biologics is a clinical-stage dermatology company developing world-class, multi-targeted therapies for serious and prevalent skin conditions 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 $9.1 million.
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