When Vivek Ramaswamy whipped up the biotech company Myovant last year, he grabbed a late-stage drug called relugolix from Takeda as their lead therapy. That drug helped win investors over to a $218 million IPO — a record for 2016. And now Myovant $MYOV is laying out some of Takeda’s mid-stage data to demonstrate what the company hopes to see in the late-stage program.
The goal of relugolix is to reduce heavy menstrual bleeding in women with uterine fibroids. And that’s just what the high dose in the trial — the 40 mg dose being studied in Phase III — accomplished. Looking to reduce a score of at least 120 required at study entry to less than 10 from Week 6 through Week 12 on the Pictorial Blood Loss Assessment Chart, or PBAC, 73% of the women on the 40 mg dose achieved a score of 0.
None of the women in the placebo group hit 0 and Myovant says the drug clearly hit the primary endpoint in the study.
At Week 12, researchers said that the 40-mg group “demonstrated an absolute reduction in myoma and uterine volumes of approximately 50% from baseline compared to placebo.”
Investigators tested a 10 mg, 20 mg and 40 mg dose in the mid-stage trial. The company didn’t break down the results by dose in its release but said the results were all dose dependent.
Takeda, which has been restructuring its pipeline, has an equity stake in Myovant.
Ramaswamy has raised a considerable sum of cash from investors convinced that he can turn some of Big Pharma’s second-tier drugs or castoffs into a Phase III hit with a near-term shot at the market. His first big test will be for Axovant $AXON later this year, which is due to deliver Phase III data on an experimental Alzheimer’s 5HT6 drug obtained from GSK.
“These data provide a strong basis for our ongoing phase 3 studies, LIBERTY 1 & 2, which are evaluating relugolix co-administered with low-dose hormonal add-back therapy in women with uterine fibroids and heavy menstrual bleeding,” said Lynn Seely, the CEO of Myovant Sciences. “Myovant hopes to provide women with a well-tolerated medical therapy to treat symptoms of uterine fibroids as an alternative to hysterectomy and other invasive procedures commonly performed to treat this condition.”
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