- Myovant Sciences (NYSE:MYOV) completes enrollment in the first of two Phase 3 replicate clinical trials, SPIRIT 2, evaluating relugolix combo therapy in women with endometriosis-associated pain.
- The co-primary endpoints are the proportion of responders based on daily assessment of non-menstrual pelvic pain and dysmenorrhea (menstrual cramps) at week 24.
- Topline data should be available in Q1 2020 followed by results from SPIRIT 1 in Q2 2020.
- The company expects to file a U.S. marketing application in Q4 seeking approval to use relugolix to treat women with heavy menstrual bleeding and uterine fibroids.
- Relugolix will compete with AbbVie's (NYSE:ABBV) Orilissa (elagolix).