US-based dermatology biopharma, Eirion Therapeutics, has announced positive results from its double-blind, placebo-controlled, first-in-human study of its age-related topical hair loss treatment seeing a six-fold increase in hair count over placebo.
ET-02 is a topical therapy and the company’s most advanced treatment for androgenic alopecia. The “first-in-man” trial, which enrolled 24 male patients across three US sites, met its primary endpoints of safety and tolerability. The company is also in preclinical development of an oral version of ET-02.
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Split into three cohorts, the placebo group received the vehicle for the company’s hair growth treatment with no active ingredient. The other two groups received a topical solution containing either 1.25% of ET-02 or a solution containing 5% of the investigative product.
Eiron claims that patients in the group receiving a solution of 5% saw a six-fold increase in non-vellus hair count compared to the placebo group at the end of the fifth week of the study. Additionally, the 5% ET-02 group saw an improvement of approximately 10% in non-vellus hair width over the placebo group.
The announcement follows a pre-clinical study examining the treatment using 90 human scalp tissue grafts from men with androgenic alopecia. Compared to the current standard of treatment for alopecia and male hair loss, minoxidil, ET-02 saw hair growth four times greater.
Jon Edelson, MD, CEO and President of Eirion, said: “A controlled pre-clinical study of ET-02 treating 90 human scalp tissue grafts from men who have intermediate-stage androgenic alopecia demonstrates this pharmaceutical’s potential to restore hair growth and return hair follicles to normal structure and function. 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.”
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By GlobalDataResearch by GlobalData found that in 2024 global sales for androgenic alopecia treatments reached approximately $276m. That figure is estimated to rise by $366m by the end of 2030. Androgenetic alopecia affects an estimated 50 million men and 30 million women in the US and can develop in men in their teens but is more common as a person ages. It is more common in women after menopause.
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Eirion plans to initiate a Phase II trial this year, evaluating more detail of the safety and efficacy of ET-02 over a six-month treatment period.
Jerry Shapiro, hair loss and dermatology specialist at the New York University Grossman School of Medicine, said: “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 a safety and ease-of-use standpoint.
“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,” Shapiro added.
Elsewhere in the hair loss space, Chinese-based Hope Medicine has kickstarted recruitment for a Phase II trial assessing its monoclonal antibody HMI-115 for androgenetic alopecia. It also follows after the US Food and Drug Administration (FDA) decided to keep the popular anti-baldness drug finasteride on the market despite requiring marketers to add suicidal ideation to a list of potential side effects.
