Relugolix was developed as a once-daily, oral medication alternative to invasive procedures, such as uterus removal surgery, or hysterectomy, to treat women with endometriosis and uterine fibroids, a disease affecting millions of women all over the world, as well as prostate cancer in men.
Part of a Phase 3 program launched in February, the LIBERTY 1 trial (NCT03049735) is the first of three similar Phase 3 studies, along with LIBERTY 2 (NCT03103087) and LIBERTY-EXTENSION (NCT03412890), investigating the safety and effectiveness of relugolix in women with heavy menstrual bleeding associated with uterine fibroids.
Eligibity criteria for both LIBERTY 1 and 2 is a monthly menstrual blood loss of at least 80 mL. The company expects to enroll 390 women in both studies. They will be assigned to three treatment groups: one receiving 40 mg of relugolix once daily along with hormonal add-back therapy for 24 weeks; another receiving 40 mg of relugolix once daily for 12 weeks, followed by the same daily dose with hormonal add-back therapy for an additional 12 weeks; and a placebo group.
The company expects to report top-line data for LIBERTY 1 in the second quarter of 2019, along with results from rials studying the effects of Relugoxil on endometriosis and prostate cancer.
“Completion of screening for LIBERTY is a critical milestone for our uterine fibroids program,” Lynn Seely, MD, president and CEO of Myovant, said in a press release. “We look forward to completing screening for LIBERTY 2 this quarter and reporting top-line efficacy and safety data for LIBERTY 1 in the second quarter of 2019. Today’s announcement is the first of several milestones we expect to report as we continue to diligently work toward top-line results on all of our ongoing Phase 3 clinical studies during 2019.”
The Phase 3 program also includes trials evaluating relugolix for women with endometriosis-related pain, SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331). Both studies are currently recruiting patients.
Myovant plans to submit a new drug application to the U.S. Food and Drug Administration for relugolix if the results of the LIBERTY 1 and 2 trials show positive effects.
These and other achievements were presented by Seely on behalf of Myovant at the first annual Roivant Pipeline Day July 10 via a live webcast. A replay of the presentation will be available for 30 days following the conference.
Takeda, which holds the commercial rights to relugolix in parts of Asia, recently granted Aska Pharmaceuticals commercialization rights to the therapy for the treatment of uterine fibroids and development and commercialization for endometriosis treatment in Japan.