Dive Brief:
- London-based Ergomed has entered into a co-development agreement with Asarina Pharma of Sweden to develop Sepranolone (UC1010) as a targeted treatment for patients with premenstrual dysphoric disorder (PMDD).
- Under the agreement, Ergomed will conduct Asarina's multi-national, multi-site randomized Phase 2b clinical trial of the therapy. The study is slated to begin in 2017.
- Ergomed said November 1 that it will co-invest in the clinical trial in return for an equity stake in Asarina.
Dive Insight:
PMDD, the most severe form of premenstrual syndrome, affects roughly 5% of women of reproductive age. Cyclic symptoms, which can be debilitating, include depression, anxiety, irritability and extreme mood shifts. According to the Mayo Clinic, current treatments include antidepressants, birth control pills, nutritional supplements, herbal remedies, and diet and lifestyle changes.
Sepranolone is the first product developed exclusively for PMDD. Asarina said its exploratory study of 120 women with PMDD found that the treatment induced a statistically significant improvement in symptoms compared to placebo, had an acceptable safety profile and was well tolerated.
Ergomed's stock had its "buy" rating restated by Stifel Nicolaus in a report released November 1. Other equities research analysts reiterated "buy" ratings on Ergomed's shares in September and October, prior to announcement of Ergomed's partnership with Asarina to evaluate the PMDD treatment.