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Monday, 02/10/2020 8:58:54 AM

Monday, February 10, 2020 8:58:54 AM

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Myovant Sciences Announces 88% One-Year Response Rate in Positive Phase 3 LIBERTY Extension Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
GlobeNewswire GlobeNewswire•February 10, 2020
Primary efficacy endpoint met with 87.7% response rate at one year; women experienced, on average, an 89.9% reduction in menstrual blood loss
Bone mineral density maintained through one year, with no new safety signals
Data further strengthen the New Drug Application (NDA) expected to be submitted in April 2020
BASEL, Switzerland, Feb. 10, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (MYOV), a healthcare company focused on developing innovative 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) demonstrated an 87.7% response rate at one year while maintaining bone mineral density. Myovant expects to include the extension data in its New Drug Application (NDA) submission for heavy menstrual bleeding associated with uterine fibroids anticipated in April 2020.

“With an estimated quarter of a million U.S. women undergoing hysterectomies each year due to fibroids, there is an urgent need to rethink how we approach the condition and associated symptoms which can be debilitating and recurrent 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 non-invasive treatment option that could provide long-term symptom improvement and ease of use would be a game-changer for physicians and millions of women who suffer from this common condition.”

In the primary endpoint analysis, 87.7% of women achieved the responder criteria defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. The one-year primary endpoint result in the LIBERTY open-label extension study demonstrated durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year.

“We are very pleased to see that at one year both the safety and efficacy data for relugolix combination therapy are consistent with our prior data demonstrating a predictable and clinically-meaningful reduction in menstrual blood loss while maintaining bone health,” said Lynn Seely. M.D., CEO of Myovant. “We look forward to submitting applications to the regulatory agencies in Europe and the U.S. in the coming months to seek approval for our one pill, once-a-day potential new treatment for women with uterine fibroids.”

Changes in bone mineral density through one year, as assessed by dual energy x-ray absorptiometry (DXA) every three months, were consistent 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 observed. Adverse events reported in more than 10% of women treated with relugolix combination therapy for one year and more frequent than those reported in the placebo group after 6 months included only hot flash. There were no pregnancies reported in the relugolix combination therapy group.

Complete results from the LIBERTY open-label extension study will be submitted for presentation at a future scientific meeting and publication in a medical journal.

About the Phase 3 LIBERTY Program in Uterine Fibroids
Myovant’s Phase 3 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 heavy menstrual bleeding associated with uterine fibroids. 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. 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 received 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 could 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.

About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.

Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as abnormal uterine bleeding, heavy or painful periods, anemia, abdominal pain, backache, increased abdominal girth and bloating, urinary frequency or retention, constipation or painful defecation, pregnancy loss, painful intercourse and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.

An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated three million women are inadequately treated by current medical therapy and require further treatment.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding with associated uterine fibroids and for women with pain associated with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.