Endometriosis One of Several Female, Male Hormonal Problems at Top of New Myovant Sciences Focus

Endometriosis One of Several Female, Male Hormonal Problems at Top of New Myovant Sciences Focus

TakedalogoTakeda Pharmaceutical Company Limited, based in Tokyo, and Roivant Sciences, in Bermuda, have partnered to form the startup firm Myovant Sciences –  a biopharmaceutical company for developing and marketing innovative women’s health and prostate cancer treatments.

Appointed President and CEO is Dr. Lynn Seely.  Seely led development of the prostate cancer drug Xtaxdi (enzalutamide) while she was chief medical officer from 2005-2015 of Medivation, a U.S. biopharmaceutical company.

MyovantlogoMyovant Sciences’ lead product development program is the oral once-daily relugolix  – a gonadotropin-releasing hormone (GnRH) receptor antagonist for treatment of uterine fibroid, endometriosis, and hormone-sensitive prostate cancer (HSPC).

Currently a Phase 3 drug candidate, relugolix has been evaluated in more than 1,300 patients so far. Myovant reports that the candidate has successfully demonstrated significant clinical benefits and has been generally well-tolerated across large, randomized Phase 2 clinical trials for uterine fibroids, endometriosis and HSPC.

Clinical experience to date, supported by an extensive preclinical development program, suggests that relugolix could be an important advancement in treatment options available for women battling endometriosis and uterine fibroids. Additionally the drug could provide men with HSPC with a new treatment alternative to injectable therapies.

According to Myovant, by inhibiting GnRH receptors in the pituitary gland, relugolix rapidly reduces circulating sex hormone levels leading to suppression of estrogen and testosterone. Suppression of the sex hormones improves symptoms experienced by women with uterine fibroids and endometriosis, and decreases prostate-specific antigen (PSA) levels in men with HSPC.

In the 2014 paper Suppression of the hypothalamicpituitarygonadal axis by TAK-385 (relugolix), a novel, investigational, orally active, small molecule gonadotropin-releasing hormone (GnRH) antagonist: Studies in human GnRH receptor knock-in mice, researchers reported substantial findings.

They concluded that TAK-385 (relugolix) may provide useful therapeutic interventions in hormone-dependent diseases including endometriosis, uterine fibroids and prostate cancer.

The paper was published in the European Journal of Pharmacology.

In a 216-patient Phase 2 study for the treatment of uterine fibroids, women who received relugolix had a significant reduction in menorrhagia, or abnormally heavy bleeding during menstruation. In a 487-patient Phase 2 study for the treatment of endometriosis, women who received relugolix had a significant reduction in both non-menstrual and menstrual pelvic pain.

Myovant is also developing RVT-602 for treatment of female infertility, specifically in-vitro fertilization (IVF). The novel, oligopeptide kisspeptin receptor agonist (formerly TAK-448) stimulates physiologic release of GnRH and other downstream fertility-supporting hormones such as luteinizing hormone.

Recent evidence gathered from women undergoing IVF reveals that native kisspeptin peptide can potentially act as an alternative to human chorionic gonadotropin (hCG) or GnRH agonists in triggering egg maturation, an essential step in IVF cycles.

Movant intends to eventually expand its product development pipeline to include other potential treatments for endocrine-related disorders.

TakedaHQTakeda has granted Myovant an exclusive license to relugolix, but Takeda will retain commercial rights for the drug in Asian countries, including Japan, where the company is actively conducting two Phase 3 registration studies for treatment of uterine fibroids. Takeda has also granted Myovant an exclusive, worldwide license to RVT-602. Financial terms of the partnership were not disclosed.

PlumpA“With Takeda strengthening its focus around the core therapeutic areas of oncology, gastroenterology and central nervous system diseases, as well as establishing a strategy that embraces innovative partnerships, it is important that we seek alternatives to further develop and create value around promising assets that are either outside these areas of focus or where strategic partnership makes more sense for our business,” said Dr. Andrew Plump, Takeda‘s chief medical and scientific officer.

RamaswamyV“We are very pleased to partner with Takeda to meet the needs of patients suffering from hormone-driven diseases and disorders,” said Vivek Ramaswamy, CEO of Myovant. “The creation of Myovant enables a ‘win-win’ outcome for both our partner and for patients by launching a company to address major unmet medical needs in women’s health, prostate cancer and beyond.”

SrrlyL Seely said she looks forward to “delivering on” Myovant’s mission.

“Relugolix and our partnership with Takeda represent an exceptional foundation on which to build this exciting new company,” Seely said in a press release.