- Statistically significant improvements in IGA (Investigator Global Assessment) and EASI (Eczema Area and Severity Index) scores
- Fast itch reduction by day 4 and sustained itch reduction
- Body Surface Area (BSA) reduction of at least 50 percent
- Significant improvement in Skin Infection Rating Scale (SIRS)
ANNAPOLIS, Md., July 10, 2023 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, today announced new data from the first cohort of its Phase 2a clinical trial program of AB-101a, a first-in-class topical candidate for treating atopic dermatitis (AD) in children ages 2 through adult. The data show significant skin clearance of the disease, itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.
The randomized, double-blind, vehicle-controlled trial evaluated the safety and efficacy of AB-101a, a hydrogel topical utilizing Alphyn's proprietary AB-101 Multi-Target Therapeutic Platform, in 41 patients at seven sites for four weeks. The randomization resulted in an 81 percent mild AD enrollment, a study population that is difficult to show improvement resulting from 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:
- AB-101a reached statistical significance for improvement in Investigator Global Assessment (IGA) score, with IGA score reaching clear or almost clear in only four weeks, a remarkable result for only 41 patients, and in the 81 percent mild AD population in which improvement is difficult to demonstrate.
- AB-101a reached statistical significance for improvement in Eczema Area and Severity Index (EASI) score, including reaching EASI 75 score in this difficult patient population and short study period.
- Significant and steady improvement through the trial in Skin Infection Rating Scale (SIRS), demonstrating control of the bacterial microbiome on the AD skin to manage AD flares and prevent infection.
- Fast itch reduction by Day 4.
- Itch score improvement equal to or greater than 4 in the pediatric group continuously increased and was sustained after the dosing stopped.
- Body Surface Area (BSA) reduction of at least 50 percent.
"Overall, these findings are clear and compelling," said CEO Neal Koller. "While we are particularly excited about the statistically significant improvements in IGA and EASI scores, which were notably achieved in an overwhelmingly mild population with only 41 patients and in only four weeks, we are also very encouraged by the fast itch reduction and unique aspects of skin microbiome control to manage AD flares which are primarily caused by bacteria."
AB-101a is being studied in two cohorts of 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 bacterial microbiome on the AD skin. 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 from July 13-16.
Alphyn is developing AB-101a as the first therapeutic for AD to treat the immune system component and the bacterial complications of the disease, including those commonly associated with Staph (Staphylococcus aureus) and methicillin-resistant Staph (MRSA). AB-101a is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-inflammatory, anti-pruritic, and antibacterial activity, indicating AB-101a should be effective in AD. 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 finance this program.
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 AD with secondary infection. 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 Australian subsidiary. The company became operational in 2020 and has raised approximately $9.1 million.
View original content:https://www.prnewswire.co.uk/news-releases/alphyn-biologics-presents-new-data-from-phase-2a-trial-showing-significant-improvement-of-mild-to-moderate-atopic-dermatitis-301873420.html
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