Asian trial backs Takeda and Myovant’s relugolix in uterine fibroids

Lynn Seely - Myovant
Myovant CEO Lynn Seely says data support the phase 3 program for the drug in U.S. and Europe.

A body of evidence is building behind Takeda and Myovant’s hormonal therapy in uterine fibroids, with late-stage Japanese data reinforcing positive phase 2 results with the drug in the U.S.

The latest phase 3 trial showed that the oral drug matched older uterine fibroid treatment leuprorelin acetate—which is given by a monthly injection—in alleviating symptoms. The 24-week trial enrolled 280 Japanese women with symptomatic uterine fibroids, benign tumors that originate in the uterus and can cause excessive menstrual bleeding and pain.

Relugolix was statistically noninferior to leuprorelin acetate on the primary endpoint of menstrual blood loss, as measured by the Pictorial Blood-loss Assessment Chart, with more than 80% of women in both groups reporting a score below the target of 10. Takeda says it plans to move ahead with regulatory filings in Japan based on the new data.

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Myovant—which licensed rights to the drug from Takeda outside certain Asian markets—reported positive results in May from a placebo-controlled phase 2 trial of the drug in uterine fibroids, and has two phase 3 trials ongoing in that indication that are due to report top-line results in early 2019.

Myovant’s CEO Lynn Seely, M.D., commented that Takeda’s data “provides strong support for Myovant’s ongoing phase 3 studies with relugolix in North America, Europe and other regions.”

Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist that has been shown to suppress testosterone levels in men and estrogen and progesterone levels in women. The drug is treading a similar path to market as Neurocrine and AbbVie’s elagolix, which was filed for endometriosis last month.

Myovant and Takeda’s drug has phase 2 data in hand for endometriosis-related pain and has also shown its mettle in phase 2 trials in prostate cancer, starting a phase 3 program for that indication in March. Prospects for the drug helped Myovant to a $218 million IPO backed by Pfizer last year, and there has been persistent speculation that Pfizer may make a play for Myovant to bolster its pipeline.

“Uterine fibroids result in debilitating heavy menstrual bleeding and anemia in millions of women throughout the world, oftentimes requiring a hysterectomy to control the bleeding,” according to Seely. 

“Myovant is working to develop relugolix, an oral, once-daily medication that can potentially provide women with an alternative option to major surgery.”

The new data is a boost for the ‘vant’ family of biotechs set up by former hedge fund manager Vivek Ramaswamy under the Roivant umbrella, going some way toward alleviating the pain felt after the failure last month of an Alzheimer’s candidate in development at Axovant.

Earlier this week, Roivant bought $116 million worth of shares in hepatitis B specialist Arbutus, in something of a departure from Ramaswamy’s usual strategy of picking up likely looking drug candidates that have been shelved by big pharma companies.