Eirion Therapeutics Inc. has announced the enrollment of the first participant in a Phase 1 clinical trial evaluating the safety of ET-02, a patented topical pharmaceutical for androgenic alopecia. The study is a double-blind, placebo-controlled trial designed to assess the safety of ET-02 with once-daily application over 28 days.
The trial aims to recruit approximately 24 subjects across three investigation centers in the United States. ET-02 features a novel mechanism of action targeting hair follicle stem cells that have become defective or inactive in individuals with age-related hair loss, with the goal of restoring these cells to normal activity and function. Hair follicle stem cells are critical regulators of hair growth, and restoring their function could lead to renewed hair growth.
Novel Mechanism Targeting Hair Follicle Stem Cells
According to Eirion Therapeutics, ET-02 directly addresses the fundamental cause of androgenic alopecia, potentially making it more effective than current treatments that do not directly impact hair follicle stem cells. Pre-clinical studies involving 90 human scalp tissue grafts from men with intermediate-stage androgenic alopecia demonstrated the pharmaceutical's potential to restore hair growth and return hair follicles to their normal structure and function.
"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, 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."
Potential for Prevention and Treatment of Hair Graying
Unlike some existing treatments, ET-02 does not target hormonal pathways, potentially avoiding side effects like sexual dysfunction. The company also believes ET-02 could treat and prevent hair graying by affecting melanocyte stem cells, which control hair color. This indication may be pursued in the future.
Eirion's Pipeline
ET-02 is the third product in development by Eirion. ET-01, a topical neuromodulator, is in Phase 2 trials with over 750 subjects studied. AI-09, a 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. Jon Edelson, MD, CEO and President of Eirion.
