Eirion Therapeutics has announced positive results from its first-in-human clinical trial of ET-02, a topical treatment for androgenic alopecia. The Phase 1 study, involving 24 male patients, met its primary endpoints of safety and tolerability, while also demonstrating a significant increase in hair growth compared to placebo.
The double-blind, placebo-controlled, dose-ranging study divided participants into three groups, receiving either a control treatment, a 1.25% solution of ET-02, or a 5% solution of ET-02. Treatments were administered once daily for four weeks, with a final assessment one week post-treatment.
Significant Hair Growth Observed
Results indicated a dose-response effect, with the 5% ET-02 group showing a six-fold increase in non-vellus hair count compared to the placebo group at the end of the fifth week. Additionally, this group experienced an approximate 10% improvement in non-vellus hair width over the placebo group.
Jon Edelson, MD, CEO and President of Eirion, stated, "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."
Comparison to Existing Treatments
In a pre-clinical study using human scalp tissue grafts, ET-02 demonstrated hair growth four times greater than minoxidil, a current standard treatment for alopecia. Jerry Shapiro, MD, a hair loss expert at NYU Grossman School of Medicine, noted that the hair growth achieved in just five weeks was "unprecedented."
Novel Mechanism of Action
ET-02 features a novel, non-hormonal mechanism of action that restores normal function to hair follicle stem cells, which are often inactive in age-related hair loss. This approach differs from existing treatments and is expected to avoid side effects like sexual dysfunction associated with androgen inhibition treatments such as finasteride.
Future Plans
Eirion plans to initiate a Phase 2 trial in 2025 to further evaluate the safety and efficacy of ET-02 over a six-month treatment period. This trial aims to confirm the promising results observed in the Phase 1 study and provide more detailed insights into the treatment's potential.
Market Context
Androgenetic alopecia affects an estimated 50 million men and 30 million women in the US. Global sales for androgenic alopecia treatments reached approximately $276 million in 2024 and are projected to increase significantly by 2030.
