Myovant Sciences completes ptient recruitment for phase III SPIRIT 2 study evaluating relugolix combination therapy in women with endometriosis

Myovant Sciences announced that it has completed patient recruitment for its SPIRIT 2 study, the first of two Phase III replicate studies evaluating relugolix combination therapy in women with endometriosis-associated pain. The SPIRIT 2 study is part of an international clinical development program designed to gain regulatory approval of relugolix for the treatment of moderate-to-severe endometriosis-associated pain.

“One in ten premenopausal women have endometriosis, a condition often associated with debilitating pain, that is particularly severe during menstruation, and infertility. Currently, the standard of care for women with moderate to severe endometriosis is invasive procedures and pain medicines, including opioids, which have significant limitations. We are developing relugolix combination therapy as a single pill taken once a day with the goal of offering patients a well-tolerated and effective alternative,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences. “With the completion of recruitment, we are on track to report top-line data for SPIRIT 2 in the first quarter of 2020, and data from our replicate study, SPIRIT 1, in the second quarter.”

About Myovant's Phase III Program for Endometriosis : Myovant is currently conducting a Phase III clinical program consisting of two international, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) of relugolix combination therapy in women with endometriosis-associated pain. Each of the SPIRIT studies is enrolling approximately 600 women 18 to 50 years of age with a diagnosis of endometriosis confirmed by laparoscopy or laparotomy. Eligible women are randomized to one of three groups: relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for 24 weeks, relugolix 40 mg monotherapy for 12 weeks followed by relugolix combination therapy for an additional 12 weeks, or placebo for a period of 24 weeks. The co-primary endpoints are evaluating the impact of treatment on menstrual pelvic pain or dysmenorrhea and on non-menstrual pelvic pain. Safety outcomes, including bone mineral density changes as measured by dual-energy x-ray absorptiometry, are also being assessed. Eligible patients completing the initial 24-week blinded assessment will be offered an active treatment extension with relugolix combination therapy for an additional 80-week period, resulting in a total treatment period of up to 104 weeks, to evaluate the safety of longer-term treatment.