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- Alphyn Biologics Achieves Positive Results in First Cohort of Phase 2a Trial for Treatment of Mild to Moderate Atopic Dermatitis
The study meets all primary objectives
ANNAPOLIS, Md., Jan. 5, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-phase dermatology company developing world-class multi-target therapeutics, today announced positive results from the first cohort of its phase-one clinical trial. 2a of AB-101a, a topical treatment for mild to moderate atopic dermatitis. The trial met all of its primary endpoints, highlighting the potential of AB-101a as an effective and safe treatment for AD.
The double-blind, randomized, vehicle-controlled trial evaluates the AB-101a treatment protocol at multiple centers using standard scales for assessing AD. The trial, conducted in Australia, enrolled 41 AD patients and treatment was evaluated after four weeks.
"As a clinician who treated 15% of the patients in the clinical trial, I am encouraged by the results of AB-101a," said Dr. Stephen Shumack, Clinical Associate Professor of Dermatology at the University of Sydney and Principal Investigator at the Center for Dermatology and Cancer. of Skin St George. "I look forward to future trials and learning more about the potential benefits of AB-101a for patients."
"Patients with mild to moderate atopic dermatitis suffer considerably from the symptoms of this often debilitating disease, but available treatments come with side effects and safety concerns," said Neal Koller, CEO of Alphyn. "We are excited about these results and look forward to the results of our ongoing treatment cohort of infected AD. We plan to study AB-101a further in a phase 2b/3 trial next year, along with funding from series B".
Alphyn plans to present the full results of this trial at a scientific conference and submit a paper for publication in a peer-reviewed journal. Enrollment in the second cohort of the Phase 2a clinical trial is ongoing. This cohort is investigating the unique ability of AB-101a to treat the infectious component of AD in AD patients with bacterial infections, including Staphylococcus aureus, or "staph," and MRSA, the antibiotic-resistant staph. Alphyn anticipates that AB-101a will be effective in treating uninfected AD and infected AD. The AB-101a should provide AD patients and physicians with a complete, 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 initiate the AB-101a clinical trial program in Phase 2 due to the strong safety profile of its AB-101 platform.
ABOUT ALPHYN BIOLOGICSAlphyn 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 infected AD. 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 benefits. 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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