Eirion Therapeutics Announces Initiation of First-in-Human Clinical Trial Evaluating Topical ET-02 for the Treatment of Androgenic Alopecia

2024-07-01

WOBURN, Mass., July 1, 2024 /PRNewswire/ -- Eirion Therapeutics Inc. announced today that the first participant has been enrolled in a Phase 1 clinical trial to evaluate the safety of the patented topical pharmaceutical ET-02 for the treatment of androgenic alopecia (age-related hair loss). This double-blind, placebo-controlled study is designed to determine the safety of ET-02 for once daily treatment over 28 days. The study is expected to recruit approximately 24 subjects at three investigation centers in the United States.

ET-02 has a novel mechanism of action which targets returning hair follicle stem cells that have become defective and / or inactive in men suffering from age-related hair loss to normal activity and function. Hair follicle stem cells are known to be the "master control switches" for hair growth. By returning stem cells to normal activity and function, the expectation is that hair can be grown normally again. Because ET-02 directly addresses what the Company believes is the fundamental cause of androgenic alopecia, the Company expects this new treatment has the potential to be significantly more effective than existing treatments which have no known direct impact on hair follicle stem cells.

"Given its postulated mechanism of action, ET-02 represents a potentially substantial advancement over commercially available pharmaceuticals for the treatment of androgenic alopecia," said Jerry Shapiro, MD, a leading expert on the treatment of hair loss and Professor of Dermatology at New York University Grossman School of Medicine. "This Phase 1 safety study is an important first step in evaluating ET-02. Assuming all goes well, this study will lead to a Phase 2 study evaluating ET-02's efficacy."

Jon Edelson, MD, CEO and President of Eirion, added, "A controlled pre-clinical study of ET-02 treating 90 human scalp tissue grafts from men who have intermediate-stage androgenic alopecia demonstrates this pharmaceutical's potential to restore hair growth and return hair follicles to normal structure and function. Because of ET-02's unique mechanism of action, we believe that ET-02 has the potential to not only treat androgenic alopecia but prevent it."

Unlike some other commercially available treatments, ET-02 does not target hormonal pathways and is not expected to have the side effects associated with such treatments, which include sexual dysfunction.

The Company believes that ET-02 also has the potential to treat and prevent hair greying by impacting the stem cell that controls hair color which is called the melanocyte stem cell. The Company plans to pursue treatment of this indication in the future. ET-02 is the third product currently in development by Eirion. ET-01 topical neuromodulator is in Phase 2 and has been studied in clinical trials with over 750 subjects in aggregate. AI-09 next-generation, ready-to-use liquid injectable neuromodulator has been studied in 96 subjects in a Phase 1 - 2 clinical trial.

"ET-02 is a highly complementary product to our two other aesthetic bio-pharmaceutical products in development, which are both potential treatments for facial wrinkles. Taking these three product candidates together, Eirion has built an exciting and robust pipeline for aesthetic medicine innovation," commented Dr. Edelson.

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.

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

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SOURCE Eirion Therapeutics, Inc.