Myovant Sciences launched in June 2016. Four months later it rallied the largest biotech IPO of the year, raising $218 million on the New York Stock Exchange.
On Thursday, the women’s health company continued its sprint-to-market, launching tw0 international Phase 3 trials — the first of five planned this year — to evaluate the safety and efficacy of its lead compound, relugolix, in women with uterine fibroids.
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That’s a productive 6-7 months.
Along with Axovant, Enzyvant and Dermavant, Myovant is a subsidiary of Roivant Sciences, a business that buys discarded compounds at a bargain price and then forms a company around them.
In an interview at the J.P. Morgan Healthcare Conference, Roivant’s Chief Development Officer William Symonds told MedCity News that the business development team looks for compounds that can deliver returns in a few years, as opposed to the ten or more years typically required for drug development. Roivant also maximizes its network and resources to give its subsidiaries a running start.
Myovant was formed around relugolix, a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist licensed from Takeda Pharmaceutical Company.
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Relugolix came ready for Phase 3 trials, having been evaluated in over 1,300 study participants in Phase 1 and multiple controlled Phase 2 clinical trials. As a once-daily pill it’s designed to reduce estrogen and progesterone levels in women and testosterone levels in men.
Myovant has three independent programs for relugolix in the works, starting with trials for heavy bleeding as a result of uterine fibroids. There is a need for more medical options. When standard hormone therapies don’t stem the bleeding, the next step is often an invasive surgical procedure.
“Every year more than 250,000 women are undergoing hysterectomy in the U.S. alone for uterine fibroids,” said Lynn Seely, president and CEO of Myovant Sciences in an email forwarded by a company representative. “We are working to bring women with uterine fibroids a once daily oral medical therapy that offers an alternative to more invasive procedures.”
Each of the two clinical trials is expected to enroll approximately 390 women at up to 200 sites worldwide. The women will be randomized into one of three arms; taking either a placebo, relugolix 40 mg as a standalone treatment, or relugolix 40 mg alongside a hormonal add-back therapy.
After the initial 24-week assessment, all patients will be offered the relugolix-hormone combination therapy for a further 24 weeks to evaluate longer-term safety.
The trial has reportedly been initiated ahead of schedule.
“If the trials prove successful, we anticipate submitting the NDA in 2019 for a potential approval as early as 2020,” Seely said via email. “There are millions of women suffering from heavy menstrual bleeding from uterine fibroids today and we want to bring them a new treatment as soon as possible.”
Myovant is planning a total of five international Phase 3 clinical trials for relugolix in 2017. Along with uterine fibroids, the company expects to launch two trials for endometriosis-associated pain in the first half of the year, following a similar study design. According to the news release, Myovant will also launch a Phase 3 trial of relugolix in men with advanced prostate cancer in the first quarter of 2017.
There’s no need to move slowly when you’ve raised $218 million in an IPO.
Photo: Maridav, Big Stock