Eirion Therapeutics Announces Initiation of First-in-Human Clinical Trial Evaluating Next Generation, Ready-to-Use Liquid Injectable Neuromodulator AI-09 for the Treatment of Wrinkles
Company Also Announces Update for Its Lead, Phase 2b Product Candidate Topical Neuromodulator ET-01
Oct 17, 2022 – Woburn, MA
Eirion Therapeutics Inc. announced today that the first participants have been dosed in a Phase 1/2 clinical trial for the treatment of glabellar wrinkles using the next generation, ready-to-use liquid injectable neuromodulator AI-09. The double-blind, placebo-controlled, dose escalation study is designed to determine the safety and optimal dose level of AI-09. The study is expected to recruit approximately 72 subjects. The study has been initiated at Baumann Cosmetic Dermatology in Miami, Florida by Leslie Baumann, MD, a leading clinical investigator in the field of aesthetic neuromodulators.
“AI-09 represents a potential real advance over commercially available injectable neuromodulators,” said Dr. Baumann. “AI-09 will be provided as a ready-to-use, liquid formulation which contrasts favorably to currently commercialized neuromodulator products that all require reconstitution with saline. Unlike most current products, AI-09 does not contain human albumin, which carries a risk of disease transmission. Finally, AI-09 can be stored at room temperature for at least 3 months, while all currently available products require shipping to, and storage at the physician’s office in refrigerated or frozen conditions.”
Jon Edelson, MD, CEO and President of Eirion, added, “We are positioning Eirion as a one-stop shop for the physician’s neuromodulator needs. Our injectable neuromodulator AI-09 is highly complementary to our potentially game-changing topical neuromodulator product candidate ET-01. With these neuromodulators and our pre-clinical product candidate ET-02 for hair loss and hair greying, Eirion is building an engine for aesthetic medicine innovation for patients around the world.”
Eirion is currently conducting a Phase 2b double-blind, placebo-controlled clinical trial studying the treatment of lateral canthal lines with topical ET-01. The first cohort of the trial (N=120) had clinically and statistically significant results, demonstrating improvements measured at muscular contraction when these wrinkles appear at their worst on the face. The second and final cohort is being enrolled, with a target of approximately 160 subjects. Earlier this year, the US Patent Office issued its first patent to Eirion covering the painless skin conditioning technique that is used prior to the application of ET-01. This technique, which creates temporary micropores in the skin, is employed by Eirion with the goal of increasing ET-01’s bioavailability to achieve the most effective treatment of wrinkles using the minimal dose of topical neuromodulator necessary. The formulation of ET-01 itself is covered by multiple patents.
Eirion also plans to file an IND for its small molecule ET-02 for the treatment of hair loss in the first quarter of next year, with the goal of having ET-02 in clinical trials in the first half of the year.
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 products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to pursue additional indications that address other major unmet clinical needs for physicians and their patients. Last year, Eirion 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.