Miami Clinical Research signed up to support Myovant Sciences to achieve top-line results for the Liberty 1 and Liberty 2 clinical trials with a focus on an investigative treatment (Relugolix) for uterine fibroids.
Miami Clinical Research was launched in 2006 by Dr. Keila Hoover, Board Certified Family Physician. The research site has conducted over 50 trials.
Myovant Sciences sponsored the Liberty 1 and Liberty 2 clinical trials. Both studies were set up to determine the benefit and safety of Relugolix 40 mg once daily co-administrated with a low dose of estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids and included secondary targeted outcomes. Liberty 1 and 2 targeted 390 participants the Miami Clinical Research was one of over 125 sites identified for both studies.
Miami Clinical Research submitted a press release showcasing their positive contribution as in July sponsor Myovant Sciences reported positive results for the Liberty 2 trial.
Liberty 2 Results
The sponsor reported that the following goals were met:
- Primary efficacy endpoint met with 71.2% response rate (p<0.0001); women experience, on average, 84.3% reduction in menstrual blood loss (p<0.0001)
- Achieved six key secondary endpoints including a reduction in pain, with a well-tolerated safety profile including the low incidence of hot flashes and bone mineral density maintained comparable to placebo
- Single-tablet Relugolix combination therapy met all required FDA bioequivalence criteria in a separate bioequivalence study supporting a potential one-pill, once-daily dosing regimen
- New Drug Application (NDA) submission expected in Q4 2019. This will be the sponsor’s application to market the drug in the United States for uterine fibroids.
What is Relugolix?
Sold under the brand name Relumnia, it is a gonadotropin-releasing hormone antagonist (GnRH antagonist) medication used in the treatment of uterine fibroids in Japan. It is under development for use in other countries and the additional indications of endometriosis and prostate cancer. Unlike most GnRH modulators, but similarly to Orilissa, Relugolix is a non-peptide and small-molecule compound and is orally active. It has also been in clinical trials for endometriosis and prostate cancer. The medication was approved for use for the treatment of uterine fibroids in Japan in January 2019. A New Drug Application of Relugolix for uterine fibroids is expected to be submitted late 2019. The drug was developed jointly with Myovant Sciences and Takeda.
What are Uterine Fibroids?
This condition occurs when benign smooth muscle tumors form in the uterus. Commonly, some women will experience no symptoms while others will experience painful and heavy period. In some extreme cases, incessant pressure stimulates frequent urination. Other conditions such as low back pain and degradation of the quality of life occur. Womenshealth.gov reports 20-80% of women will develop fibroids by the time they reach 50.
Headquartered in the United Kingdom, the biopharmaceutical company (MYOV) is dedicated to purpose-driven science and transformational medicine. They focus on unmet needs in women’s health and prostate cancer.
Like much-emerging biopharma focusing on rare or unmet needs, they operate at a deficit—nearly at $270 million loss at latest reporting. They do have a substantial market capitalization at $671 million on a share price of $7.49—this is near the 52 week low of $6.60-their high is $27.45. The stock is trading at historic lows.
Their pipeline focuses on uterine fibroids, endometriosis, and advanced prostate cancer. They have a development partnership with Takeda (Japan).
Their lead investigational drug candidate is Relugolix, a small molecule, GnRH receptor antagonist. They have three clinical programs for Relugolix consisting of five international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2), two in women with endometriosis-associated pain (SPIRIT 1 & 2), and one in men with advanced prostate cancer (HERO).
They are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, as a potential treatment for women undergoing assisted reproduction, such as in-vitro fertilization (IVF). In a Phase 2a trial, we are assessing the exposure-response profile of MVT-602 during the pre-ovulatory phase in women undergoing controlled ovarian stimulation.