Stock To Watch: ObsEva's PRIMROSE 2 Trial Meets Goals

(RTTNews) - ObsEva SA's (OBSV) phase III study of Linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids, dubbed PRIMROSE 2, has yielded positive results.

The PRIMROSE 2 trial, conducted in Europe and the US, evaluated the efficacy and safety of once-daily oral Linzagolix, including 100 mg and 200 mg doses, both with and without hormonal add-back therapy (ABT).

In the trial, which enrolled 535 women with heavy menstrual bleeding (HMB) due to uterine fibroids, the responder rate was 93.9% for women receiving 200 mg oral Linzagolix with ABT and 56.7% for women receiving 100 mg oral Linzagolix without ABT compared to 29.4% in the placebo group.

Responders were defined as patients with menstrual blood loss volume of = 80 mL and = 50% reduction from baseline in menstrual blood loss volume at 24 weeks.

Both doses achieved important clinically relevant secondary endpoints including amenorrhea, reduction in pain, improvement in quality of life and improvement in hemoglobin levels, noted the Company.

Results from the second pivotal study of Linzagolix, dubbed PRIMROSE 1, conducted in the US, are expected in the second quarter of 2020.

If everything goes well, the company expects to seek approval for Linzagolix in Europe by year-end 2020 and in the U.S. by the first quarter of 2021.