Myovant Sciences has reported positive results from the Phase III LIBERTY 2 study of its relugolix combination therapy for the treatment of uterine fibroids.
The trial met its primary efficacy endpoint and six key secondary endpoints.
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist designed to reduce the production of ovarian estradiol, a hormone involved in uterine fibroids growth.
The LIBERTY 2 study assessed the drug’s combination therapy of 40mg relugolix, 1mg estradiol, and 0.5mg norethindrone acetate in a total of 382 patients.
Primary endpoint analysis of the trial showed that responder criteria has been reached in 71.2% of subjects on relugolix combination therapy versus 14.7% in the placebo group.
Response was determined based on a menstrual blood loss volume of less than 80ml and a 50% or greater decrease in the volume from baseline during the last 35 days of therapy.
Myovant noted that participants in the combination therapy arm had an average of 84.3% reduction in menstrual blood loss from baseline.
Patients with moderate-to-severe pain due to uterine fibroids also experienced no pain or minimal pain during the last 35 days of treatment with the combination.
Changes in bone mineral density were observed to be comparable between the treatment and placebo arms over 24 weeks.
Statistical significance was also achieved for six key secondary endpoints of mean change in menstrual blood loss from baseline to week 24, reduction in pain in women, improvement in quality of life, amenorrhea, anaemia, and decrease in uterine volume.
Relugolix combination therapy was generally well-tolerated during the trial, with overall incidence of adverse events in the treatment and placebo groups being comparable.
Myovant Sciences president and CEO Lynn Seely said: “With these results, our team is focused on submitting the NDA by the end of the year and continuing to build the organisation and capabilities to efficiently and successfully deliver this treatment to women in need.”
The company also announced that a separate study of single-tablet relugolix combination therapy met all required US Food and Drug Administration (FDA) criteria for bioequivalence.
In May this year, the company reported positive data from the Phase III LIBERTY 1 trial of the combination in 388 uterine fibroids patients.