Annapolis, Maryland (ots/PRNewswire) – The study met all primary endpoints
Alphyn Biologics, a clinical trials dermatology company developing world-class multi-target therapeutics, today announced positive results from the first cohort of its Phase IIa clinical trial of AB-101a, a topical therapeutic for mild to moderate atopic dermatitis (AD ). The study met all primary endpoints, underscoring the potential of AB-101a as an effective and safe treatment for AD.
In the randomized, double-blind, vehicle-controlled study, the multi-site AB-101a treatment protocol will be evaluated using standard AD assessment scales. The study, conducted in Australia, involved 41 AD patients and the treatment was evaluated after four weeks.
“As a physician who treated 15 percent of the patients in the clinical study, I am encouraged by the results of AB-101a,” said Dr Stephen Shumack, Associate Clinical Professor of Dermatology at the University of Sydney and Principal Investigator at St George’s Dermatology & Skin Cancer Centre, “I look forward to future studies and a better overall picture of the potential benefit of AB-101a to patients.”
“Patients with mild to moderate atopic dermatitis suffer significantly from the symptoms of this often debilitating disease, yet available treatments come with side effects and safety concerns,” said Neal Koller, CEO of Alphyn. “We welcome these results and look forward to the results of our ongoing cohort to treat infected AD. We plan to further investigate AB-101a in a Phase IIb/III study this year in conjunction with Series B funding.”
Alphyn intends to present the full results of this study at a scientific conference and to submit an article for publication in a peer-reviewed journal. The second cohort of the Phase IIa clinical trial is currently being recruited. This cohort will explore AB-101a’s unique ability to treat the infected component in AD patients suffering from bacterial infections, including Staphylococcus aureus and “staph,” and MRSA, the antibiotic-resistant staph. Alphyn anticipates that AB-101a will be effective in treating uninfected and infected AD. AB-101a is intended to provide AD patients and physicians with a comprehensive, safe, and convenient provide treatment options.
AB-101a was developed based on Alphyn’s proprietary AB-101 platform. The platform features multiple bioactive agents and thus multiple mechanisms of action to address multiple issues of any target disease. Alphyn was able to enter Phase II of the AB-101a clinical trial program due to the strong safety profile of its AB-101 platform.
ABOUT ALPHYN BIOLOGICS Alphyn Biologics is a clinical-stage dermatology company developing first-in-class, multi-target therapeutics for serious and common 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 in development to target the immune system and bacterial components of atopic dermatitis. This makes it ideal for treating AD and infected AD. Alphyn’s AB-101 platform has multiple bioactive compounds, and therefore multiple mechanisms of action, supporting a robust pipeline of dermatological therapeutics with potential safety, efficacy and regulatory benefits. Alphyn is based in Annapolis, Maryland and Cincinnati, Ohio with a wholly owned subsidiary in Australia. The company began operations in 2020 and has raised approximately $6.9 million.
Questions & contact:
Company: Neal Koller,
fork@alphynbiologics.com,
(410) 690-8687; Media: Susan Thomas,
susan@endpointcommunications.net,
(619) 540-9195