- Alphyn Biologics Reveals Encouraging Interim Results From Phase 2a Trial For Atopic Dermatitis With Secondary Bacterial Infection
Topical treatment is achieving all efficacy and safety endpoints in mild, moderate, and severe atopic dermatitis
ANNAPOLIS, Md. and ASHEVILLE, N.C., July 14, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing the first Multi-Target Therapeutics®, today released interim results from the second cohort of its Phase 2a clinical trial program of AB-101a, a new topical candidate for atopic dermatitis (AD). Interim results evaluating AB-101a on the immune and bacterial components of AD show that the therapeutic candidate meets all efficacy and safety endpoints.
For the bacterial component of the disease, AB-101a is eliminating all AD infections and is demonstrating control of the bacterial microbiome on AD skin to control bacterial-induced outbreaks at mild, moderate, and severe levels of disease. For the immune system component of AD, AB-101a reduces itching and shows improvement in Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores of AD. The results were presented in a poster at the annual meeting of the Society for Pediatric Dermatology.
This second cohort of the Phase 2a trial program is multi-site and has completed enrollment. It is expected to conclude with 19 patients. Results from 7 to 10 patients are included in the interim evaluation.
The provisional results are:
"While tentative and reflect approximately half of the trial population, the results we are publishing today are extremely encouraging," explained Neal Koller, CEO of Alphyn, "We believe that AB-101a could be well suited for continued use over long-term for all levels of Alzheimer's disease severity, from mild to severe, and potentially the first to treat bacterial infections associated with Alzheimer's disease and to manage the skin microbiome for better control of AD flare-ups ".
AB-101a is being studied in two cohorts of a Phase 2a clinical trial program. The first cohort of 41 patients with mild to moderate AD was evaluated in a randomized, double-blind, vehicle-controlled trial. Results published earlier this month at the World Congress of Dermatology demonstrate significant improvements in disease extent and severity, reduced itch, and better control of the bacterial microbiome in AD skin, demonstrating the ability to control the outbreak of AD caused by bacteria.
Alphyn is developing AB-101a as the first AD treatment 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, single-source complex botanical novel drug with multiple bioactive compounds that provides multiple mechanisms of action, including anti-inflammatory, antipruritic, and antibacterial activity, indicating that AB-101a may be effective in GIVES. 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. Alphyn is raising its Series B equity financing.
ABOUT ALPHYN BIOLOGICS Alphyn Biologics is a clinical-stage dermatology company developing first-of-its-kind Multi-Target Therapeutics® 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 under development to uniquely target the immune system and bacterial components of AD, making it ideal for treating AD and AD with secondary bacterial infection. Alphyn's AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust line of dermatologic therapies that have potential safety, efficacy, and regulatory marketing authorization advantages. Alphyn is headquartered in Annapolis, Maryland and Cincinnati, Ohio, and has a wholly owned Australian subsidiary. The company began operations in 2020 and has raised approximately $9.1 million.
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