• Top-line results for SPIRIT 2 and SPIRIT 1 expected in the first and second quarters of 2020, respectively
  • Studies support potential regulatory submission for a single tablet, once-daily treatment of moderate-to-severe endometriosis-associated pain

BRISBANE, CA, USA and BASEL, Switzerland I October 21, 2019 I Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, today announced that it has completed patient recruitment for its SPIRIT 1 study, the second of two Phase 3 replicate studies evaluating relugolix combination therapy in women with endometriosis-associated pain.

“The completion of recruitment for the SPIRIT program marks another important step in achieving our goal to bring a best-in-class, non-invasive treatment option to women suffering from endometriosis, that has predictable efficacy and tolerability and is potentially suitable for long-term use,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences. “We are extremely appreciative of the physicians and patients who participate in our clinical trials and have helped us reach this important milestone. We look forward to sharing the top-line results in the first and second quarters of 2020.” 

About the Phase 3 SPIRIT Program
Myovant Sciences’ Phase 3 clinical program for endometriosis consists of two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis-associated pain. Each of the SPIRIT studies was designed to enroll approximately 600 women 18 to 50 years of age with a diagnosis of endometriosis confirmed by laparoscopy or laparotomy. Eligible women have been randomized to one of three groups: relugolix combination therapy 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 evaluate the impact of treatment on menstrual pelvic pain, or dysmenorrhea, and 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.

About Endometriosis
Endometriosis is a disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. This endometrial-like tissue outside the uterus results in chronic inflammation and can cause scarring and adhesions.

The symptoms associated with endometriosis include painful periods and chronic pelvic pain, painful ovulation, pain during or after sexual intercourse, heavy bleeding, fatigue, and infertility. Endometriosis can also impact general physical, mental, and social well-being.

For endometriosis-associated pain, initial treatment options include oral contraceptives and over-the-counter pain medications. In more severe cases, GnRH agonists such as leuprolide acetate are used for short-term treatment. An estimated six million women in the U.S. suffer from symptoms of endometriosis, and an estimated one million women are inadequately treated by current medical therapy and require further treatment.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant Sciences is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with endometriosis-associated pain. Myovant is also evaluating relugolix monotherapy (120 mg once daily) in men with advanced prostate cancer.

About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer. The company’s lead product candidate is relugolix, a once-daily oral GnRH receptor antagonist. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis and prostate cancer. The company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has completed a Phase 2a study for the treatment of female infertility as part of assisted reproduction. Takeda Pharmaceuticals International AG granted the company an exclusive, worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive license to develop and commercialize MVT-602 in all countries worldwide. For more information, please visit the company’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

SOURCE: Myovant Sciences