ICYMI: Eirion ET-02’s Successful Phase 1 Trial Results for Androgenic Alopecia Treatment

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Yesterday, Eirion Therapeutics announced positive results for its first in-man clinical trial of pharmaceutical, small molecule ET-02 in the treatment of androgenic alopecia.¹ The topical therapy was safe and well-tolerated, with results being observed in as early as 5 weeks.

In a statement, Jerry Shapiro, MD, professor of dermatology at New York University Grossman School of Medicine, said, "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.”¹

The double-blind, placebo-controlled, phase 1 clinical study included 24 participants and took place at 3 investigational sites in the United States. Patients received either a control vehicle, a 1.25% solution of ET-02, or a 5% solution of ET-02 once a day for 4 weeks.

The higher-dosed 5% solution showed a significant response with a 6-fold increase in normal hair count. This was noted at the end of week 5. According to the investigators, 1 month of 5% ET-02 treatment showed more hair growth after 4 months of topical minoxidil therapy, which is the current gold standard for androgenic alopecia. This was demonstrated in a separate clinical trial of minoxidil with 180 participants.

There was also a 10% improvement in non-vellus hair width, compared to the unchanged growth noted in the placebo group. These results confirm what was demonstrated in a pre-clinical controlled study evaluating the 5% ET-02 on 60 scalp tissue grafts from males with androgenic alopecia.

ET-02 is not expected to have the same adverse effects that are associated with androgen inhibition treatments, like finasteride, due to its non-hormonal mechanism of action. Its once-a-day dosage can also be more convenient compared to other therapies that are applied twice a day.

The novel therapy restores the normal function and activity of inactive hair follicle stem cells, which restores and promotes growth. This defect creates age-related hair loss and is believed to be the fundamental cause of androgenic alopecia, according to Eirion. This approach differs from other products that are commercially available or in development.

ET-02 may have the potential to treat and prevent hair greying by targeting the melanocyte stem cells in the same manner. Other dermatologic indications, which have not yet been disclosed, could also potentially use ET-02 as a treatment.

"80 million people in the United States suffer from hair loss and there is no truly effective treatment for this condition today, CEO and President of Eirion, Jon Edelson, MD, said in a press release. “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."¹

To confirm ET-02’s efficacy and safety, a phase 2 clinical trial is set to begin later in the year. This will involve 150 patients over a 6-month treatment period.

Reference

1. Eirion Therapeutics Announces Potential Breakthrough Treatment for Hair Loss Based on First-in-Man Clinical Trial Results. News release. PR Newswire. January 8, 2025. Accessed January 9, 2025. https://www.prnewswire.com/news-releases/eirion-therapeutics-announces-potential-breakthrough-treatment-for-hair-loss-based-on-first-in-man-clinical-trial-results-302344730.html