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Study met all primary endpoints
ANNAPOLIS, Md., Jan. 4, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing first-in-class multi-target therapeutics, announced today positive results from the first cohort of its Phase 2a clinical trial of AB-101a, a topical therapeutic for mild-to-moderate atopic dermatitis (AD). The trial met all of its primary endpoints, highlighting AB-101a's potential to be an effective and safe treatment for AD.
The randomized, vehicle-controlled, double-blind trial is evaluating the treatment protocol of AB-101a across multiple sites using standard scales for assessing AD. The trial, conducted in Australia, enrolled 41 AD patients, and treatment was evaluated after four weeks.
"As a physician who treated 15 percent of the patients in the clinical trial, I am encouraged by the results with AB-101a," said Dr. Stephen Shumack, Clinical Associate Professor Dermatology, University of Sydney, and Principal Investigator at St George Dermatology & Skin Cancer Centre. "I look forward to future trials and gaining a better understanding of AB-101a's potential benefits for patients."
"Patients with mild-to-moderate atopic dermatitis suffer considerably from the symptoms of this often debilitating disease, yet available treatments come with side effects and safety concerns," said Alphyn CEO Neal Koller. "We are excited by these results and look forward to the results of our ongoing cohort treating infected AD. We plan to further study AB-101a in a Phase 2b/3 trial next year in conjunction with a Series B financing."
Alphyn intends to present the full results of this trial at a scientific conference and submit a paper for publication in a peer-reviewed journal. Enrollment is ongoing in the second cohort of the Phase 2a clinical trial. This cohort is investigating the unique ability of AB-101a to treat the infected component of AD in AD patients who are suffering from bacterial infections, including Staphylococcus aureus, or "Staph," and MRSA, the antibiotic-resistant Staph. Alphyn anticipates AB-101a will be effective in treating non-infected AD and infected AD. AB-101a should provide AD patients and physicians a comprehensive, safe, and convenient treatment option.
AB-101a was developed using Alphyn's proprietary AB-101 platform. The platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to address multiple problems of any target disease. Alphyn was able to begin the AB-101a clinical trial program in Phase 2 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 severe 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 in development to uniquely target AD's immune system and bacterial components, making it ideal for treating AD and infected AD. Alphyn's AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential safety, efficacy and regulatory marketing authorization advantages. Alphyn is based in Annapolis, Maryland and Cincinnati, Ohio, and has a wholly owned Australia subsidiary. The company became operational in 2020 and has raised approximately $6.9 million.