Eirion Therapeutics Announces Results of First-in-Human Clinical Trial Evaluating Ready-to-Use Liquid Injectable Neuromodulator AI-09 for the Treatment of Wrinkles

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WOBURN, Mass., Oct. 1, 2024. Eirion Therapeutics Inc., a biopharmaceutical company focused on developing innovative aesthetic prescription product offerings, announced today that successful results had been achieved in its Phase 1 - 2 clinical trial for the treatment of moderate to severe glabellar wrinkles using its next generation, ready-to-use liquid injectable neuromodulator AI-09. The double-blind, placebo-controlled, dose escalation study studying 96 subjects at four U.S. investigational sites found AI-09 to be safe and well tolerated. The study found that a dose-response pattern was evident both in terms of efficacy and duration of response. The higher doses tested demonstrated clinically and statistically significant efficacy results. The median duration of response for the highest dose tested was 26 weeks or 6 months. Duration of response was based on maintaining a ≥1 point improvement from baseline on the 4-point scale used by the investigators to assess wrinkle severity.

"AI-09 first-in-human clinical trial achieved all study objectives for safety, efficacy and duration", said Leslie Baumann, MD, a leading clinical investigator in the field of aesthetic neuromodulators and the principal investigator in the study. "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."

Eirion also announced completion of a survey of over 800 U.S. residents assessing the importance of duration of response. Survey respondents all had been treated in the past with a neuromodulator for their glabellar wrinkles ("frown lines"). The survey was comprised of approximately half women and half men. When asked if a botulinum treatment for frown lines that lasted 6 months would be better for them:

  • 97% of respondents responded it would be better for them.
  • 63% of respondents reported that this improvement would be "a lot better" or "amazingly better."
  • Considering female respondents, the percentage indicating it would be "a lot better" or "amazingly better" went up to 73%.

    • Jon Edelson, MD, CEO and President of Eirion, added, "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, including our complementary Phase 2 topical neuromodulator product and Phase 1 small molecule product candidate for hair loss. We are energized by the progress across the breadth of our aesthetic product candidates."

    Eirion Therapeutics will participate in The Medical Aesthetic Injectable Summit taking place October 4 – 5, 2024, in Marbella, Spain. Dr Edelson will present an update on its neuromodulator product candidates during the conference session "Disruptive Innovations in Toxins & Injection Tools" that will take place on Friday October 4 12:00 PM – 1:15 PM CET. This presentation follows the recent publication of a review article on topical neuromodulators that Dr Edelson authored which appeared in Dermatologic Surgery.

    About Eirion Therapeutics, Inc.

    Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of product candidates focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. Eirion's product candidates include AI-09 liquid injectable neuromodulator, ET-01 topical neuromodulator, and ET-02 small molecule for hair loss and hair greying. In the future, Eirion plans to pursue additional indications that address other major unmet clinical needs for physicians and their patients. In support of its development work, Eirion has previously closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Co., Ltd in China and a strategic manufacturing deal with HTL Biotechnology in France.

    SOURCE Eirion Therapeutics, Inc.

    Posted : 2024-10-02 12:00

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