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.

Alphyn Biologics’ topical AB-101a showed significant skin clearance in AD along with  itch reduction, and control of flares by treating the bacterial microbiome on the skin, according to new data from the first cohort of a Phase 2a clinical trial program.

The data was presented at the World Congress of Dermatology in Singapore.

Alphyn is developing AB-101a to treat the immune system component and the bacterial complications of AD, 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. 

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% 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.  The new data showed that 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% mild AD population in which improvement is difficult to demonstrate.

AB-101a also 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.

There was a 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. The study also noted itch reduction by Day 4, and itch score improvement equal to or greater than 4 in the pediatric group continuously increased and was sustained after the dosing stopped. There was also a Body Surface Area (BSA) reduction of at least 50%, the study showed.

"Overall, these findings are clear and compelling," says CEO Neal Koller in a news release. "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, 2023.