UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

NEW YORK, LONDON,, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that Myovant Sciences’ Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The dat a are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021. Myovant is a healthcare company focused on redefining care for women and for men, and one of five healthcare companies in the Sumitovant family of companies.

“This relugolix development milestone continues to further the mission of Sumitovant Biopharma to support the advancement of therapies that make a difference in the lives of patients, especially women of child-bearing years experiencing the pain of endometriosis," said Myrtle Potter, Chief Executive Officer of Sumitovant Biopharma.

In the SPIRIT long-term extension study, 84.8% and 73.3% of women receiving relugolix combination therapy over one year achieved clinically meaningful pain reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. On average, women reported an 82.8% reduction on the 11-point Numerical Rating Scale (0-10) for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain) over one year.

“Building on the strength of our one-year data of relugolix combination therapy in uterine fibroids, we are pleased by the one-year safety and efficacy data in women with endometriosis, which further our vision for a one pill, once-a-day treatment option suitable for long-term use in both diseases,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “We look forward to submitting a New Drug Application for this potential new treatment for women with endometriosis in the first half of this year.”

Bone mineral density remained stable through Week 52 in women treated with relugolix combination therapy after minimal, non-clinically meaningful bone loss through Week 24. The incidence of adverse events over one year was consistent with that observed in SPIRIT 1 and SPIRIT 2, with no new safety signals observed. The most commonly reported adverse events in at least 10% of women treated with relugolix combination therapy were headache, nasopharyngitis, and hot flashes. There was one pregnancy reported in the relugolix combination therapy group (n = 278).

Data from SPIRIT 1 and SPIRIT 2 studies were previously presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress. Complete results from the SPIRIT long-term extension study will be submitted for presentation at a future scientific meeting and publication in a medical journal.

About the Phase 3 SPIRIT Program in Endometriosis
The 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 over 1,200 women with pain associated with endometriosis. Women received treatment either with relugolix combination therapy for 24 weeks, relugolix 40 mg once daily monotherapy for 12 weeks followed by relugolix combination therapy once daily for an additional 12 weeks, or placebo once daily for 24 weeks. Eligible women who completed the SPIRIT 1 or SPIRIT 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women receive relugolix combination therapy for an additional 80-week period, resulting in a total treatment period of up to 104 weeks, designed to evaluate the safety and sustained efficacy of longer-term treatment.

About Endometriosis
Endometriosis is an estrogen-dependent, inflammatory 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, requiring a multi-disciplinary approach to care.

For endometriosis-associated pain, per current guidelines, initial treatment options include hormonal contraceptives and over-the-counter pain medications. In more severe cases, LHRH 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. Almost 200 million women are affected globally.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitovant Biopharma Ltd.
Sumitovant Biopharma Ltd. is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant, and Altavant. Sumitovant's promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. For further information about Sumitovant, please visit https://www.sumitovant.com. Follow Sumitovant on LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

Myovant Sciences Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; the expected timing and strength of Myovant’s regulatory filings; the potential for relugolix combination therapy to significantly and durably reduce pain in women with endometriosis with a well-tolerated safety profile; the potential for relugolix combination therapy to evolve the treatment paradigm for women with endometriosis; and Myovant’s vision for a one pill, once-a-day, treatment option suitable for long-term use in uterine fibroids and endometriosis.

Myovant Sciences' forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences' filings with the United States Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on November 12, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences' management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.