Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids

• Seven oral and poster presentations presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress
• Oral presentation on efficacy and safety data from Phase 3 SPIRIT program selected as the best clinical abstract in endometriosis
• Oral presentation on efficacy and safety data from the LIBERTY long-term extension study in uterine fibroids selected as a prize paper
  

BASEL, Switzerland, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and in women with uterine fibroids. The data were presented in virtual oral and poster sessions during the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress, held October 17-21, 2020.

“For millions of women, the symptoms of endometriosis and uterine fibroids, such as pain and heavy menstrual bleeding, can be highly debilitating and have a significant impact on their daily lives,” said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences. “These additional data further support our vision for a one pill, once-a-day treatment that provides symptom relief with minimal side effects, potentially allowing for long-term treatment of women suffering from these common chronic conditions.”

Details of the presentations from studies of women with endometriosis are as follows:

The Phase 3 SPIRIT program evaluated the efficacy and safety of once-daily relugolix combination therapy in women with endometriosis. The SPIRIT 1 and 2 studies achieved their co-primary endpoints, demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain.

• Efficacy and Safety of Relugolix Combination Therapy in Women with Endometriosis-Associated Pain: Phase 3 Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT 1 and 2) (oral presentation, O-187, Endometriosis Special Interest Group Prize Paper [Best in Clinical/Population Science])
  In the SPIRIT 1 and 2 studies, relugolix combination therapy resulted in a clinically meaningful reduction in dysmenorrhea (74.5% vs. 26.9% and 75.2% vs. 30.4% for SPIRIT 1 and 2, respectively) and non-menstrual pelvic pain in women with endometriosis (58.5% vs. 39.6% and 66.0% vs. 42.7% for SPIRIT 1 and 2, respectively) compared with placebo (p < 0.0001 for both co-primary endpoints in both studies). Dysmenorrhea rapidly decreased from severe at baseline to mild by Week 8 which was sustained through Week 24. Non-menstrual pelvic pain decreased from moderate at baseline to mild over 24 weeks. Both studies also met several key secondary endpoints including reduction in dyspareunia (painful intercourse) and the EHP-30 pain domain. Changes in bone mineral density over 24 weeks were minimal in the relugolix combination therapy group.