Oral GnRH receptor antagonists for endometriosis Phase 2 Clinical End.

On June 23, Myovant Sciences published the top-line results of the SPIRIT 1 study, the second phase III study to evaluate the relugolix combination therapy (relugolix 40mg plus estradiol 1.0mg plus acetate ketone 0.5mg) to treat pain associated with endometriosis in womenThe data showed that the relugolix combination therapy reached the common primary therapeutic endpoint and all seven key secondary endpoints compared to placebosIn the study, the relugolix combination therapy was well tolerated and 24 weeks of treatment showed minimal bone density lossSPIRIT included two cross-border, repetitive critical clinical studies (SPIRIT 1, SPIRIT 2) in more than 1,200 women with endometriosis pain, evaluating the efficacy and safety of the relugolix combination therapyIn the study, patients were randomly divided into three groups and received: relugolix combination therapy, once a day, for 24 weeks; relugolix monodrug therapy, one treatment once a day for 12 weeks, then relugolix combination therapy for 12 weeks at a time, and placebo, once a day, for 24 weeksApril, the company published the results of the SPIRIT 2 study: the relugolix combination therapy reached the common primary efficacy endpoint and all six key secondary endpoints compared to placebosSPIRIT 1 results were consistent with SPIRIT 2, with a common primary endpoint analysis that showed that the relugolix combination therapy group had 74.5 percent of the combined therapies group, 26.9 percent of the placebo group had clinically significant reduction of pain (p 0.0001); On average, on the 11-point (0-10) numerical score scale, the relugolix combination therapy group's pain score decreased from 7.3 to 1.8 (mild), with a decrease of 73.3 percent, the relugolix combination therapy was statistically significant compared to placebo sando seis ionas for all seven key secondary endpoints measured at the 24th week, including: changes in average pain and overall pelvic pain, the effects of pain on daily activities, a higher proportion of women who did not use painkillers (average p.0001), and women without opioids (p.00005)studies, the relugolix combination therapy was well tolerated and had minimal bone density loss within 24 weeks of treatmentThe total incidence of adverse events in the Relugolix combination therapy group was similar to that of the placebo group (71.2% vs 66.0%)In the relugolix combination therapy group, 3.8 percent of women stopped treatment for adverse events, while the placebo group stopped treatment at 1.9 percentIn the relugolix combination therapy group, at least 10% of women reported adverse events such as headaches and hot flashesThe Relugolix combination therapy group had 1 pregnancy and the placebo group had 3 casesqualified women who completespirit1 and SPIRIT 2 and have the opportunity to participate in an active treatment extension study, with 80 weeks of relugolix combination therapy for a total duration of 104 weeks, an extended study designed to assess the safety and sustainability of long-term treatment of relugolix combination therapy, with one-year data expected in the first quarter of 2021relugolix chemical structureRelugolix is a daily oral donadotropin release hormone (GnRH) receptor antagonist that reduces the production of ovarian stenol , a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testosterone, a hormone known to stimulate prostate cancer growthMyovant is developing a relugolix compound tablet for the treatment of uterine fibroids and endometriosis, and relugolix single tablets for advanced prostate cancerTo date, relugolix has achieved positive results in 5 phase III studies of 3 indicationsRelated Reading:oral GnRH receptor antagonists prostate cancer stage III clinical outcomes are superior
regulatory aspects, Myovant has submitted to the FDA relugolix monosinofa for prostate cancer, relugolix compound tablets to treat uterine fibroids new drug application (NDA)One-year data from the SPIRIT Extended Study, together with DATA from SPIRIT 1 and SPIRIT 2, will together form the NDA for the treatment of endometriosis-related pain in the relugolix combination therapySource: Myovant Sciences Announces Positive Results From Second Phase 3 Study Evaluating Once-Daily Relugolix The Syndares in Women with Endometriosis.