Eirion Therapeutics Inc., a biopharmaceutical company focused on developing innovative aesthetic prescription product offerings, has officially announced the successful results from its first-in-man clinical trial, where the company used its topical pharmaceutical ET-02 to treat androgenic alopecia (age-related hair loss).
More on the given trial would reveal how it was a double-blind, placebo-controlled, dose-ranging clinical study of 24 subjects at three U.S. investigational sites. During the course of this exercise, three equal-sized groups were treated once daily for 4 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 was made one week after the treatment formally concluded.
Talk about the results, we begin from how the drug in question was found to be safe and well tolerated among subjects. Next up, we must dig into dose-response. You see, a minimal response was observed in the vehicle and 1.25% ET-02 groups. Markedly enough, in contrast, a significant response was observed in the higher dose 5% ET-02 group. For better understanding, the placebo group actually made up the combined vehicle and 1.25% ET-02 dose groups.
Moving on to how much hair growth was actually observed, the 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. To expand upon that, 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.
Having referred to hair growth, we now must turn our attention towards hair width. Here, 5% ET-02 resulted in an approximately ten percentage point improvement in non-vellus hair width over the placebo group. The placebo group, on its part, was largely unchanged.
“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. 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,” said Jerry Shapiro, MD, Professor of Dermatology at New York University Grossman School of Medicine.
Taking a slightly deeper view of the drug itself, ET-02 has a novel mechanism of action which 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. As hair follicle stem cells are known to be the most crucial aspect for hair growth, correcting the stated defect and returning the stem cells to normal activity and function can restore hair growth. Not just hair loss, Eirion is preaching the use of ET-02 to treat and prevent hair greying as well. The drug will achieve that by impacting, in a similar manner, the melanocyte stem cells which control the production of hair color.
Among other things, we ought to mention that Eirion’s first-in-man study results actually confirm the efficacy of 5% ET-02 as demonstrated in a previous controlled pre-clinical study of topical 5% ET-02. During this pre-clinical study, ET-02 was used on 60 subjects and it emerged as markedly more effective than the control group. To put that into perspective, 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).
“ET-02 is being tested as a once-a-day treatment, rather than the less convenient twice-a-day regimen required for topical minoxidil,” said Dr Shapiro, “I look forward to future clinical studies of ET-02.”
