Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, today announced that LIBERTY 1, the first of two Phase 3 studies of once daily relugolix combination therapy met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. Relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated.
In the primary endpoint analysis, 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo (p < 0.0001). A response was 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 last 35 days of the 24-week treatment period measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline, a clinically relevant key secondary endpoint.
Bone mineral density was comparable between the relugolix combination and placebo groups. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA).
"We are incredibly pleased with the positive results of this first Phase 3 study demonstrating a clinically meaningful response in a high proportion of women while maintaining bone health," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant. "These results substantiate our once daily oral combination therapy approach. The improvements in symptoms most relevant to women, such as reduction in menstrual blood loss and pain, and improvement in quality of life are particularly exciting. We look forward to the possibility of bringing a new treatment option, suitable for long-term use, to the millions of women suffering from this debilitating disease."
"Women with uterine fibroids have limited medical treatment options and suffer from heavy menstrual bleeding, pain, anemia, and other symptoms that can significantly decrease their quality of life," said Ayman Al-Hendy, M.D., Ph.D., Professor and Director, Translational Research, University of Illinois College of Medicine. "These results highlight the potential of a once daily oral medicine to become an important option to help women with uterine fibroids manage symptoms without invasive procedures or major surgery such as hysterectomy."
The 24-week study achieved six key secondary endpoints with statistical significance compared to placebo including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea defined as no or negligible blood loss, improvement in anemia in those women with anemia at baseline, and reduction in uterine volume.
The overall incidence of adverse events in the relugolix combination and placebo groups was comparable (62% vs. 66%). In the relugolix combination therapy group 5% of women discontinued treatment early due to adverse events compared with 4% in the placebo group. The only adverse event in the relugolix combination arm occurring in at least 10% of women and more frequently than in the placebo arm was hot flush (11% versus 8%). There were no pregnancies in the relugolix combination group and one in the placebo group.
Myovant expects data from LIBERTY 2, the replicate Phase 3 study evaluating once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding, in the third quarter of 2019 and, provided the LIBERTY 2 study is successful, plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the fourth quarter of 2019.
Phase 3 LIBERTY Program in Uterine Fibroids
Myovant’s ongoing Phase 3 clinical program for uterine fibroids consists of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids and heavy menstrual bleeding. Women in the LIBERTY 1 and LIBERT...
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