Novel topical yields results ‘never seen’ for androgenic alopecia

Key takeaways:

• ET-02’s novel mechanism of action restores normal function to hair follicle stem cells that are inactive from age.
• Application of ET-02 over a 4-week span yielded a sixfold increase in non-vellus hair count.

Topical ET-02 demonstrated successful results in its first-in-human clinical trial for the treatment of androgenic alopecia, Eirion Therapeutics announced in a press release.

“Right now, 80 million people in the United States suffer from hair loss and there is no truly effective treatment for this condition,” Jon Edelson, MD, CEO and president of Eirion, told Healio. “Current treatments like minoxidil require two skin applications daily across many months to see a relatively small result. ET-02 has the potential to change the standard of care.”

ET-02 is a topical formulation with a novel mechanism of action which restores normal function to hair follicle stem cells that have become in active due to a defect in stem cell biology that develops with age, according to the press release. ET-02 reportedly corrects that defect, resulting in hair regrowth.

In this double-blind, placebo-controlled, dose-ranging study, 24 patients with androgenetic alopecia were treated with once-daily ET-02 1.25%, ET-02 5% or vehicle for 4 weeks.

The investigators found that those treated with the 5% formulation saw much better results than those using the 1.25% dose. As a result, the investigators combined results from the vehicle and ET-02 1.25% dose groups to make the placebo group.

Results observed 1 week after the end of the study showed that ET-02 5% applied once-daily for 4 weeks yielded a sixfold increase in non-vellus hair count vs. the placebo group. The treatment also resulted in an improvement of approximately 10 percentage points in non-vellus hair width compared with the placebo group.

The researchers also compared the results of this study with results from a separate clinical trial of minoxidil and concluded that 5% ET-02 yields more non-vellus hair growth over the span of 4 weeks than minoxidil produced over 4 months.

As far as side effects, the researchers stated that ET-02 will not cause the typical side effects seen in other hair loss treatments such as minoxidil or finasteride, the latter of which is the most recent age-related hair loss treatment having been approved in 1997.

“ET-02 has a novel nonhormonal mechanism of action that doesn’t cause side-effects like sexual dysfunction,” Edelson said. “The dermatology community has been waiting a long time for a more effective and safer product. Our data are encouraging, and we have hopes that we can deliver this to them in ET-02.”

Edelson told Healio that the company has planned a phase 2 trial that will assess ET-02’s success in treating androgenetic alopecia over the span of 6 months. Due to the robust response in this trial, the company is reportedly eager to see future results.

“It has been energizing to hear the positive responses from the dermatology community and from experienced researchers who have never seen results like this before,” Edelson said.