Eirion Therapeutics Announces Potential Breakthrough Treatment for Hair Loss Based on First-in-Man Clinical Trial Results

Demonstrates Potential for ET-02 to be Significantly More Effective Than Existing Treatments for Hair Loss

WOBURN, Mass., Jan. 8, 2025 /PRNewswire/ -- Eirion Therapeutics Inc., a biopharmaceutical company focused on developing innovative aesthetic prescription product offerings, announced today the successful results of its first-in-man clinical trial for the treatment of androgenic alopecia (age-related hair loss) using its topical pharmaceutical ET-02.

Jon Edelson, MD, CEO and President of Eirion, commented "80 million people in the United States suffer from hair loss and there is no truly effective treatment for this condition today. Because of ET-02's unique mechanism of action, we believe that ET-02 has the potential to not only treat but prevent androgenic alopecia. The results of this clinical trial show we are an important step closer to potentially having a solution for hair loss."

In a double-blind, placebo-controlled, dose-ranging clinical study of 24 subjects at three U.S. investigational sites, three equal-sized groups were treated once daily for 4 weeks with either a control treatment comprised of the product vehicle, a 1.25% solution of ET-02 or a 5% solution of ET-02. A final assessment of the subjects was made one week after the treatments ended. Key results of the study showed:

• Safety: ET-02 was found to be safe and well tolerated.
• Dose-Response: A dose-response effect was observed, with minimal response observed in the vehicle and 1.25% ET-02 groups compared to the significant response observed in the higher dose 5% ET-02 group. Thus, for analysis, the placebo group was the combined vehicle and 1.25% ET-02 dose groups.
• Hair Growth: 5% ET-02 resulted in a 6-fold increase in non-vellus (or normal) hair count compared to the placebo group at the end of the fifth week of the study.
  • For comparative purposes, after one month of treatment 5% ET-02 demonstrated more non-vellus hair growth than topical minoxidil produced after 4 months of treatment as measured in a separate clinical trial of minoxidil (N=180), the current "gold standard" treatment for androgenic alopecia.
• Hair Width: 5% ET-02 resulted in an approximately ten percentage point improvement in non-vellus hair width over the placebo group, which was essentially unchanged.

Eirion's first-in-man study results confirm the efficacy of 5% ET-02 as demonstrated in a previous controlled pre-clinical study of topical 5% ET-02 treating 60 human scalp tissue grafts from men with androgenic alopecia. In that study, ET-02 was markedly more effective than the control group. The net rate of hair growth produced by ET-02 in the fourth month of treatment was four times greater than the amount produced by minoxidil in a second, separate pre-clinical study (N=103) using the same experimental graft model. Eirion plans to begin a Phase 2 clinical trial (N≈150) in 2025 with a 6-month treatment period with the goal of confirming ET-02's safety and efficacy.

Jerry Shapiro, MD, a leading expert on the treatment of hair loss and Professor of Dermatology at New York University Grossman School of Medicine noted that "Eirion's clinical trial results are clear-cut and remarkable. Achieving this amount of hair growth in just 5 weeks in a clinical trial is unprecedented. ET-02 represents a potentially substantial advancement over minoxidil and other commercially available pharmaceuticals for patients struggling with hair loss, not only from an efficacy standpoint, but also from safety and ease-of-use standpoints. Due to its non-hormonal mechanism of action, ET-02 is not expected to have the same side effects that patients complain of, like sexual dysfunction, for androgen inhibition treatments like finasteride. ET-02 is being tested as a once-a-day treatment, rather than the less convenient twice-a-day regimen required for topical minoxidil." Dr Shapiro added, "I look forward to future clinical studies of ET-02."

ET-02 has a novel mechanism of action which restores normal function to hair follicle stem cells that have become inactive in age-related hair loss due to a defect that develops in the stem cell biology. Hair follicle stem cells are known to be the "master control switches" for hair growth. By correcting this defect and returning the stem cells to normal activity and function, the expectation is that hair growth can be restored. Eirion expects ET-02 has the potential to be significantly more effective than existing treatments since it directly addresses what Eirion believes is the fundamental cause of androgenic alopecia, while existing treatments do not. Eirion also believes ET-02 has the potential to treat and prevent hair greying by impacting in a similar manner the melanocyte stem cells which control the production of hair color.

Eirion Therapeutics will participate in the Aesthetics Tech Forum taking place January 9 – 10, 2025, in Newport Beach, California. Dr Edelson will present an update on Eirion and clinical trial results during the conference session "Company Presentations" that will take place on Thursday January 9^th 1:25 PM – 2:30 PM PST. 

About Eirion Therapeutics, Inc.

Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic medicine. Eirion currently has a rich pipeline of product candidates focusing on treatments for wrinkles, androgenic alopecia, hair greying and primary axillary hyperhidrosis. Eirion's product candidates, all of which have been studied in one or more clinical trials, include AI-09 liquid injectable neuromodulator, ET-01 topical neuromodulator, and ET-02 topical small molecule. 

To learn more about Eirion, please visit: www.eirionthera.com

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SOURCE Eirion Therapeutics, Inc.