Eirion Therapeutics Inc.’s topical ET-02 may be more effective than existing treatments for androgenic alopecia, according to results of a first-in-man clinical trial.
ET-02 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. By correcting this defect and returning the stem cells to normal activity and function, the expectation is that hair growth can be restored. 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.
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 four 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.
“Eirion’s clinical trial results are clear-cut and remarkable,” says Jerry Shapiro, MD, a Professor of Dermatology at New York University Grossman School of Medicine in New York, NY, in a news release. “Achieving this amount of hair growth in just five 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, he says.
Dr Shapiro adds, “I look forward to future clinical studies of ET-02.”
The findings will be presented at the Aesthetics Tech Forum in Newport Beach, CA.
