Cassiopea SpA announced the topline results of its phase II Proof of Concept (POC) trial investigating clascoterone solution for the treatment of androgenetic alopecia (AGA) in females. This Phase II vehicle and 2% minoxidil-controlled dose-ranging study was conducted in Germany and evaluated the 6-month efficacy and safety of 5.0% and 7.5% twice daily application of clascoterone solution, as compared with twice-daily 2% minoxidil or vehicle, in 293 females aged 18-55 experiencing AGA. Approximately 70 eligible subjects were randomly assigned to treatment groups or vehicle; most were Caucasian with an average age of 40.7 years for the per protocol population. The co-primary efficacy endpoints were 1) change from baseline in non-vellus Target Area Hair count (TAHC) and 2) Hair Growth Assessment (HGA) at Month 6. The target area is defined as one square centimeter. HGA was a study subject self-administered question that provided an indication of the favorability of scalp hair growth compared to baseline using a 7-point scale. AGA affects an estimated 50% of women over 40 years or an estimated 30 million women in the US.1 AGA has a complex and less understood etiology compared with male pattern hair loss, yet genetics and aging play a role in both. Although the role of androgens, androgen receptors and androgen synthesis in the skin are is less clear in female AGA, some women with AGA respond to oral androgen receptor treatments, but these therapies are associated with side effects.2 Also, consistently with previous topical hair loss studies in female subjects treated twice-daily with solutions containing propylene glycol,3 a significant placebo effect was foreseen and effectively observed, and the study was therefore expected to deliver mixed results. Also, Finasteride 1 mg/day (Propecia(R)) in a double blind 12 months trial did not increase hair growth or slowed progression of hair thinning in postmenopausal women with AGA. In the clinical trial, surprisingly, only the subgroup with women less than 30 years of age receiving twice daily application of 5% clascoterone solution showed statistically significant differences from baseline in TAHC at Month 6 (p value=0.0391) although the subgroup was not powered to show statistical significance. Cassiopea is thus encouraged by the opportunity presented by this data to continue in its effort to treat at least a significant portion of women suffering from AGA and, as a next step, will now analyze in-depth the data to identify the female subgroups that would benefit most from the treatment. At 6 months, the incidence of AEs across active groups were similar. TEAEs, if they occurred were mostly minimal, mild or trace, with the majority not deemed related to study drug by the investigators. The majority of subjects did not experience any local skin reactions (LSRs) The most frequently observed LSRs across all treatment groups at 6 months were minimal or mild scaling, minimal erythema or minimal pruritus. These data are consistent with previous studies of clascoterone solution.5,6 No substantive changes in vital signs, weight or laboratory tests at 6 months for any treatment group. Clascoterone also had encouraging results in terms of favorable cosmetic acceptability and ease of use.