Myovant/Pfizer releases clinical data for Relugolix Phase 3, a new drug for endometriosis

A combination of relugolix, estradiol and acetaminophen once a day can reduce clinically significant symptoms in endometriosis women within a year, according to the results of the latest Phase III long-term expansion study published by Pfizer and Myovant.
December, Pfizer announced that it would work with Myovant Sciences to develop and promote the oral gonthe hormone release hormone (GnRH) agent relugolix for the treatment of oncology and women's health diseases in the United States and Canada.
, Myovant will receive up to $4.2 billion in payments, including $650 million in upfront payments.
the trial is part of a SPIRIT trial between Myovant and Pfizer that looked at the treatment of endometriosis women using relugolix 40mg combined estradiol 1.0mg and acetylene 0.5mg over a 52-week period.
The positive results of this expanded study are considered consistent with the validity and safety data of the SPIRIT 1 and SPIRIT 2 III studies, which will be used to submit applications to the U.S. Food and Drug Administration (FDA) for new drugs, and the two companies are expected to file regulatory applications for joint therapies in the first half of 2021.
if approved, Myovant and Pfizer will also seek to develop a combination therapy for relugolix, estradiol and acetylene to treat uterine fibroids and endometriosis.
"Given that endometriosis often has a long-term and devastating impact on women's daily lives over many years, patients need noninvasive and long-term treatment options," Dr. Linda Giudice, a member of the steering committee for the SPIRIT trial and a professor at the Center for Reproductive Sciences at the University of California, San Francisco, said in a statement.
One year of clinical data from the SPIRIT Phase 3 Extended Study provides promising evidence of the efficacy of relugolix, demonstrating that relugolix combination therapy has the potential to significantly and lastingly reduce pain in endometriosis patients while maintaining good patient tolerance.
" trial results showed that during the one-year study period, women who received relugolix combined treatment achieved a clinically significant reduction in menstrual pain (84.8%) and non-menstrual pelvic pain (73.3%).
over a 52-week period, the scores of women on the relugolix combined treatment decreased by an average of 82.8 percent, from 7.4 (severe pain) to 1.3 (mild pain).
study, the researchers observed a relatively stable density of bone minerals in all patients treated with relugolix.
week 24, very few patients had had clinically significant bone loss under the treatment of relugolix.
compared to the safety results of the SPIRIT 1 and SPIRIT 2 studies, patients in the relugolix combined treatment group did not see new safety signals, with common adverse events (≥10 participants) including headache, nasopharyngitis, and hot water.
The drug is a daily, oral, gonom-releasing hormone (GnRH) agent antagonist, and relugolix can also reduce ovarian estraline estradiol production by blocking GnRH in the pituitary glands, a hormone known to stimulate the growth of uterine fibroids and endometriosis.
the drug was originally developed by Takeda, and Myovant," a company founded by Roivant and Takeda, was granted a global exclusive license in June 2016, with the exception of Japan and other Asian countries.
addition, the drug inhibits testosterone production, a hormone that stimulates the growth of prostate cancer.
December 2020, the drug was officially approved by the FDA as the first oral hormone therapy to treat advanced prostate cancer in adults.
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