Eirion Therapeutics has announced positive results from its Phase 1-2 clinical trial of AI-09, a ready-to-use liquid injectable neuromodulator, for the treatment of moderate to severe glabellar wrinkles. The double-blind, placebo-controlled, dose-escalation study, involving 96 subjects across four U.S. sites, demonstrated that AI-09 was safe and well-tolerated, with higher doses showing clinically and statistically significant efficacy and a median duration of response of 26 weeks. This extended duration could represent a significant advancement in the treatment of wrinkles, potentially reducing the frequency of injections for patients.
AI-09 Clinical Trial Results
The Phase 1-2 trial evaluated the safety, efficacy, and duration of AI-09 in treating glabellar wrinkles. The study's primary endpoint was to assess the safety and tolerability of AI-09, while secondary endpoints included evaluating the improvement in wrinkle severity based on a 4-point scale. Results indicated a clear dose-response relationship, with higher doses leading to greater improvements in wrinkle severity and longer duration of effect. The median duration of response for the highest dose tested was 26 weeks, defined as maintaining at least a 1-point improvement from baseline on the wrinkle severity scale.
Leslie Baumann, MD, principal investigator in the study, stated, "AI-09 first-in-human clinical trial achieved all study objectives for safety, efficacy and duration. A ready-to-use, liquid neuromodulator formulation that lasts 6 months will appeal to both physicians and patients. I look forward to further development work on this promising product candidate."
Patient Preference for Longer Duration
Eirion also conducted a survey of over 800 U.S. residents who had previously received neuromodulator treatments for glabellar wrinkles. The survey revealed that 97% of respondents indicated that a treatment lasting 6 months would be preferable. Furthermore, 63% reported that this improvement would be "a lot better" or "amazingly better," with the percentage increasing to 73% among female respondents. This data underscores the significant demand for longer-lasting neuromodulator treatments.
Eirion's Broader Pipeline
AI-09 is part of Eirion's broader pipeline of aesthetic product candidates, which includes a Phase 2 topical neuromodulator product (ET-01) and a Phase 1 small molecule product candidate (ET-02) for hair loss. Jon Edelson, MD, CEO and President of Eirion, commented, "We were excited by both the clinical trial and survey results, demonstrating that AI-09 could be an attractive treatment solution for patients and physicians. With these AI-09 clinical trial results, Eirion continues to advance its pipeline of innovative aesthetic medical product candidates... We are energized by the progress across the breadth of our aesthetic product candidates."
About Glabellar Wrinkles
Glabellar wrinkles, commonly known as frown lines, are vertical lines that appear between the eyebrows. They are caused by repeated muscle contractions associated with facial expressions. Neuromodulators, such as botulinum toxin, are commonly used to treat these wrinkles by temporarily paralyzing the underlying muscles. Current neuromodulator treatments typically require repeat injections every 3-4 months to maintain their effect. AI-09's potential for a 6-month duration of effect could significantly improve patient convenience and adherence.
