Myovant Sciences’ (MYOV) phase III LIBERTY extension study of once-daily Relugolix combination therapy in women with uterine fibroids has yielded encouraging results.
The study has demonstrated an 87.7% response rate at one year while maintaining bone mineral density. The women experienced, on average, an 89.9% reduction in menstrual blood loss.
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and can cause debilitating symptoms such as abnormal uterine bleeding, heavy or painful periods to name a few.
The phase III LIBERTY program consists of two clinical trials – LIBERTY 1 and LIBERTY 2.
Results from the LIBERTY 1 trial were reported last May, and the trial met its primary efficacy endpoint with a highly statistically significant 73.4% response rate, and women experiencing, on average, an 84.3% reduction in menstrual blood loss.
Results from LIBERTY 2 trial were reported last July, wherein the primary efficacy endpoint was met with a 71.2% response rate, and the women experienced, on average, an 84.3% reduction in menstrual blood loss.
The LIBERTY extension study involved eligible women who completed the LIBERTY 1 or LIBERTY 2 studies and they were treated with Relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks.
Myovant expects to include the extension data in its New Drug Application seeking approval of Relugolix for heavy menstrual bleeding associated with uterine fibroids, which is expected to be filed with the FDA in April 2020. A Marketing Authorization Application for Relugolix in the above indication is expected to be submitted to the European Medicines Agency in the first quarter of the calendar year 2020.
— Myovant anticipates submitting its NDA for Relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.
— Topline data from two replicate phase III studies evaluating the safety and efficacy of Relugolix combination therapy in women with pain associated with endometriosis, dubbed SPIRIT 2 and 1 are expected in the first and second quarters of calendar year 2020, respectively.
As of December 31, 2019, the Company had cash, cash equivalents, and marketable securities of $98.9 million and $286.3 million of available borrowing capacity under the loan facility from Sumitomo Dainippon Pharma.
MYOV is trading at $13.64, up 4.84%.
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