Clinical-stage biopharmaceutical company Myovant Sciences has commenced a Phase III clinical trial (HERO) of relugolix for the treatment of advanced prostate cancer.
Relugolix is an oral, small-molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist, designed to block the pituitary release of the luteinizing hormone and follicle-stimulating hormone, resulting in a decrease of testosterone.
The randomised, open-label, parallel-group Phase III international trial will evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who need a minimum of one year of continuous androgen deprivation therapy.
The firm intends to enrol up to 1,125 patients in North and South America, Europe and the Asia-Pacific region.
Myovant Sciences president and chief executive officer Dr Lynn Seely said: "Our hope is that relugolix will be able to provide the therapeutic benefits of direct testosterone suppression with a GnRH antagonist coupled with the convenience of a once-a-day pill.
"This international clinical trial designed to gain approval in the United States, Europe, and Asia will be the critical test to achieve that objective."
It is expected that the once-daily oral GnRH antagonist will reduce testosterone within days of initiation and will allow a rapid return of testosterone when discontinued.
The trial's primary efficacy outcome is the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels for 48 weeks.
The Phase I and multiple large-controlled Phase II clinical trials conducted in more than 1,300 subjects showed that relugolix is well tolerated and can suppress testosterone levels in men, as well as estrogen and progesterone levels in women.