Alphyn Biologics, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, released interim results today from the second cohort of its Phase 2a clinical trial program of AB-101a, a novel topical candidate for atopic dermatitis (AD).
The interim results evaluating AB-101a on the immune and bacterial components of AD show the therapeutic candidate is meeting all endpoints for efficacy and safety.
For the disease’s bacterial component, AB-101a is clearing all AD infections and is demonstrating control of the bacterial microbiome on the AD skin to manage flares driven by bacteria in mild, moderate, and severe levels of the disease.
For AD’s immune system component, AB-101a is reducing itch and showing improvement in the Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) AD scores. The results were presented in a poster at The Society for Pediatric Dermatology annual meeting.
This second cohort of the Phase 2a trial program is multisite and has completed enrollment. It is expected to conclude with 19 patients. Results from between 7 and 10 patients are included in the interim evaluation.
Interim results are as follows:
- 80 percent of patients achieved itch score improvement of 4 or greater
- 90 percent of patients had an EASI score improvement of at least 50 percent; 44 percent of patients had an EASI score improvement of 75 percent
- 40 percent of patients experienced a reduction of disease severity, as indicated by 2 or greater improvement in the IGA score, with 64 percent achieving clear or almost clear
- 100 percent of patients had their infections cleared, and 82 percent achieved a SIRS (Skin Infection Rating Scale) score improvement of 6 or more points, equal to an improvement of 55 to 75 percent
- All patients showed a steady decrease in SIRS score, demonstrating control of the AD skin bacterial microbiome and control of the AD flares caused by bacteria
- Effectiveness against bacteria was equivalent to treatment with the gold-standard Vancomycin; one incidence eliminated bacteria resistant to Vancomycin
- Only one Treatment Emergent Adverse Event (TEAE) was reported, showing a strong safety and side effect profile
“While interim and reflective of about half of the trial population, the results we are releasing today are extremely encouraging,” said Alphyn CEO Neal Koller. “We believe that AB-101a could be well suited for long-term, continuous use for all severity levels of AD – from mild to severe – and potentially the first to treat bacterial infections associated with AD and to manage the skin microbiome to better control AD flare-ups.”
AB-101a is being studied in two cohorts of a Phase 2a clinical trial program. The first cohort of 41 patients with mild-to-moderate AD was evaluated in a randomized, double-blind, vehicle-controlled trial. Results released earlier this month at the World Dermatology Congress demonstrate significant improvements in disease extent and severity, itch reduction, and improved control of the bacterial microbiome on the AD skin, showing the ability to manage AD flare caused by bacteria.
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 provides multiple mechanisms of action, including anti-inflammatory, anti-pruritic, and antibacterial activity, indicating AB-101a could 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. Alphyn is raising its Series B equity financing.