Positive results from phase III LIBERTY 1 & 2 studies of relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids.- Myovant Sciences

Myovant Sciences announced that results from its Phase III LIBERTY 1 & 2 studies of relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids will be presented in the late-breaking oral session at the 2019 American Society for Reproductive Medicine (ASRM) Scientific Congress , which is being held October 12-16 in Philadelphia, Pennsylvania.

Both Phase III studies met their primary efficacy endpoint with relugolix combination therapy demonstrating significant reduction in heavy menstrual bleeding (p < 0.0001) in women with uterine fibroids. Key secondary endpoints including a reduction in mean menstrual blood loss volume, achievement of amenorrhea (defined as no or negligible menstrual bleeding), reduction in pain associated with uterine fibroids, improvement in anemia, reduction in distress from bleeding and pelvic discomfort, and reduction in uterine volume were also met in both studies with statistical significance. The safety profile of relugolix combination therapy in both studies was generally well-tolerated with bone health maintained and vasomotor symptoms comparable to those in the placebo group. In addition, Myovant Sciences will present a poster on the development and validation of the bleeding and pelvic discomfort scale, a patient-reported outcome for women with heavy menstrual bleeding associated with uterine fibroids.

Presentation details are as follows :Oral Presentation: Session: OR03-15 - Late-Breaking 1 Title: "Treatment of Symptoms of Uterine Fibroids with Relugolix Combination Therapy: Efficacy and Safety Results from the Phase 3 LIBERTY 1 Clinical Trial"- Abstract #: O-265. Presenter: Ayman Al-Hendy, MD, PhD, University of Illinois College of Medicine. Session Date & Time: Wednesday, October 16, 12:00 p.m. EDT. Poster Presentation : Session: Poster Session 2; P02-16 - Fibroids: Title:" Measuring Patient-Reported Outcomes in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids: The Bleeding and Pelvic Discomfort Scale"- Abstract #: P-595 Presenter: Juliet Li, PhD, Myovant Sciences Session Date & Time: Wednesday, October 16, 6:30�7:45 a.m.

Phase III LIBERTY Program : Myovant Sciences� Phase III clinical program for uterine fibroids consisted 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 LIBERTY 2 studies underwent a screening period requiring up to two menstrual cycles to document heavy menstrual bleeding and were randomized in a 1:1:1 ratio to one of three groups. 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. Myovant Sciences enrolled 388 women in LIBERTY 1 and 382 women in LIBERTY 2. To be enrolled, women must have had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles or 160 mL in one cycle, measured by the alkaline hematin method, a quantitative measure of menstrual blood loss from an assessment of collected menstrual products. Eligible women who completed the LIBERTY 1 or LIBERTY 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 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and sustained efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women can elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy, and to evaluate the need for maintenance therapy.