Myovant Sciences Ltd. (NYSE: MYOV) was founded on February 2, 2016, formerly known as Roivant Endocrinology Ltd., changed to its current name in May 2016, headquartered in London, UK, with 104 full-time employees (6/30/ 2018), is a clinical-stage biopharmaceutical company with 3 companies under its umbrella: Myovant Sciences, Inc. (Delaware company), Myovant Holdings Limited (a private limited company incorporated under the laws of England and Wales) ), Myovant Sciences GmbH (a limited liability company established under Swiss law). Myovant Sciences Ltd., like Axovant Gene Therapies Ltd. , Urovant Sciences Ltd. and Dermavant Sciences Ltd. , are all listed subsidiaries of Roivant Sciences Ltd. in the UK .
Myovant Sciences (MYOV):
Myovant Sciences is a clinical-stage biopharmaceutical company focusing on the development and commercialization of innovative therapies for women’s health diseases and other endocrine-related diseases. The company’s leading product candidate is relugolix, an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone (GnRH), a receptor antagonist. Myovant Sciences is advancing Relugolix to treat pain associated with uterine fibroids, endometriosis and heavy menstrual bleeding associated with advanced prostate cancer.
To date, Relugolix has been evaluated in more than 1,300 subjects, some of which are ongoing in phase I and multiple large randomized phase II clinical trials. These tests produced favorable results in each indication. In these trials, it was shown that relugolix is generally well tolerated and successfully suppressed estrogen and progesterone levels in women and testosterone levels in men. The suppression of estrogen and progesterone levels in women has been shown to be effective in treating symptoms of uterine fibroids and endometriosis, and the suppression of testosterone levels in men has been shown to be effective in treating advanced prostate cancer.
In a double-blind, placebo-controlled phase 2 clinical trial of 216 women, relugolix significantly reduced menstrual blood loss associated with uterine fibroids. The results were statistically significant for each treatment group and placebo, and the maximum therapeutic effect was recorded at a dose of 40 mg per day (p <0.0001). In a double-blind, placebo-controlled phase II clinical trial in 487 women with endometriosis, relugolix reduced the pelvic pain associated with endometriosis.
In two randomized phase II clinical trials in 228 men with advanced prostate cancer, relugolix demonstrated the ability to reduce testosterone to very low levels and reduce the level of prostate-specific antigen, which is key Prostate cancer biomarkers. These results of relugolix are consistent with the results of leuprolide acetate (a GnRH agonist commonly used in androgen deprivation treatment) and four degarelix (injectable GnRH antagonists). Unlike GnRH agonists, these trials show that relugolix rapidly reduces testosterone levels when administered orally once a day.
Myovant Sciences plans to start three multinational phase III clinical projects for relugolix:
- In the first quarter of 2017, severe menstrual bleeding related to uterine fibroids;
- In the first half of 2017, women’s pain related to endometriosis;
- In the first quarter of 2017, men had advanced prostate cancer.
Myovant Sciences expects to report the results of these phase III clinical trials in 2019.
In addition, Myovant Sciences is also developing its second product-RVT-602, an oligopeptide kisspeptin analogue, as part of assisted reproduction for the treatment of female infertility. Kisspeptin is a naturally occurring peptide that stimulates the release of GnRH. RVT-602 has been evaluated in approximately 150 men, but has not been studied in women. In the second half of 2017, we expect to start the first phase of healthy volunteer research on women, followed by the second phase of proof-of-concept trial of RVT-602. Myovant Sciences believes that RVT-602 may be a safer alternative to human chorionic gonadotropin, as part of assisted reproduction for the treatment of female infertility, based on published data to evaluate native kisspeptin in women undergoing assisted reproduction .
Myovant Sciences Ltd. and Flo Health have developed a digital tool for screening heavy menstrual bleeding.
Myovant Sciences (MYOV) investment:
Myovant Sciences Ltd. (NYSE: MYOV) submitted the IPO prospectus on 9/30/2016, and listed on the NYSE on 10/27/2016. The issue price was US$15.00, 14.5 million shares were issued, and the fundraising was US$217.5 million, stock code : MYOV.