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.
Details of the presentations from studies of women with uterine fibroids are as follows:
The Phase 3 LIBERTY program evaluated the efficacy and safety of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding associated with uterine fibroids in two replicate studies, LIBERTY 1 and 2. The primary endpoint of both studies was met with a significant proportion of women treated with relugolix combination therapy achieving the responder criteria for reduction in menstrual blood loss compared with placebo after 24 weeks of treatment (p < 0.0001 in both studies). Eligible women who completed the studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of 52 weeks.
Details of presentations from additional studies are as follows:
Relugolix combination tablet is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020.
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of 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. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer.
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 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. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. 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.
This press-release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding Myovant Sciences’ intent, belief, or expectations regarding future events or results and can be identified by words such as “anticipate,” “aspire,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements and quotes regarding Myovant Sciences’ aspirations to redefine care for women and for men; Myovant’s 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 and chronic conditions; the characterizations of the data presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress; the FDA target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA) for Myovant’s NDA for the treatment of men with advanced prostate cancer and the target action date of June 1 for Myovant’s NDA for the treatment of women with uterine fibroids. 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. 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 August 11, 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. 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.
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