MYOV stock is extremely volatile in pre-market trading on February 10, 2020, after the company reported earnings and trial results.
Yovant Sciences (NYSE: MYOV), a health care business lazer focused on creating new treatments for women’s health and prostate cancer, today announced that the Phase 3 LIBERTY open-label extension study of once-daily, oral relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) showed an 87.7% response rate at one year when preserving bone mineral density. Myovant expects to incorporate the expansion data in its New Drug Application (NDA) submission for heavy menstrual bleeding associated with uterine fibroids expected in April 2020.
“With an estimated quarter of a million U.S. women undergoing hysterectomies each year because of fibroids, there’s an urgent need to rethink how we approach the condition and associated symptoms which may be debilitating and continuing for many women,” said Ayman Al-Hendy, M.D., Ph.D., professor of obstetrics and gynecology and director of Translational Research, University of Illinois College of Medicine. “A noninvasive treatment alternative that could provide long-term symptom improvement and ease of use would be a game-changer for doctors and millions of women who suffer from this common condition.”
In the principal endpoint analysis, 87.7percent of girls achieved the responder criteria defined as a menstrual blood loss volume of less than 80 mL and a 50 percent or greater reduction from baseline in menstrual blood loss volume during the past 35 days of treatment measured using the alkaline hematin method. The one-year main endpoint lead to the LIBERTY open-label expansion study revealed durability of this response observed in LIBERTY 1 and 2. Additionally, women experienced, normally, an 89.9% decrease in menstrual blood loss from baseline at one year.
“We are extremely happy to see that at one year both the efficacy and safety data for relugolix combination treatment are consistent with our prior data demonstrating a predictable and clinically-meaningful decrease in menstrual blood loss while preserving bone health,” said Lynn Seely. “We anticipate submitting applications to the regulatory agencies in Europe and the U.S. in the coming months to seek approval for our one tablet, once-a-day possible new treatment for women with uterine fibroids.”
Changes in bone mineral density during one year, as measured by dual energy x-ray absorptiometry (DXA) every 3 months, were in-line with those in LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals detected. Adverse events reported in over 10 percent of women treated with relugolix combination therapy for a year and more frequent than those reported in the placebo group after 6 weeks comprised only hot flash.
Myovant Sciences announced recent company updates and reported financial results for its third fiscal quarter ended December 31, 2019.
Third Fiscal Quarter 2019 and Present Business Highlights
- In November 2019, Myovant said the Stage 3 HERO study assessing the efficacy and safety of once-daily, oral relugolix monotherapy (120 mg) over 48 weeks in 934 men with advanced prostate cancer met its primary efficacy endpoint with a 96.7% response rate and all tested crucial secondary endpoints, while showing 54% fewer major cardiovascular events as compared with leuprolide injections administered every 3 months. Myovant anticipates submitting its NDA for relugolix monotherapy pill for men with advanced prostate cancer at the next quarter of calendar year 2020.
- In February 2020, Myovant announced positive one-year safety and effectiveness data in the LIBERTY open-label extension research with an 87.7% reaction rate and, normally, an 89.9% decrease in menstrual blood loss from baseline, while demonstrating maintenance of bone mineral density during one year in-line with LIBERTY 2 and 1. Myovant hopes to submit its NDA for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids in April 2020. The NDA submission, for which Myovant no longer expects to use a priority review voucher, will include complete one-year safety and efficacy data from the LIBERTY open-label extension research, key data which may positively affect the branded duration of usage of the relugolix combination tablet.
- Myovant completed patient recruitment in SPIRIT 2 in August 2019 and at SPIRIT 1 in October 2019, enrolling 623 women and 638 women, respectively. The SPIRIT 1 and 2 are replicated Phase 3 studies assessing the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis. Myovant expects to report top-line outcomes from SPIRIT 2 and SPIRIT 1 at the first and second quarters of calendar year 2020, respectively.
In December 2019, Myovant successfully finished one-year stability studies for the relugolix combination tablet in service of potential commercialization.
“The next six months promise to be an inflection point for Myovant as we expect to submit NDAs for prostate cancer and uterine fibroids in the U.S. and announce data from two Phase 3 studies in endometriosis,” said Lynn Seely, M.D., CEO of Myovant. “We are preparing to potentially bring two distinct one pill, once-a-day treatments to the many women and men who suffer from these common diseases. The low-interest loan facility from Sumitomo Dainippon Pharma strengthens our financial position and further supports this vision.”