ObsEva wraps up patients recruitiment for testing linzagolix, to treat certain heavy menstrual bleeding

ObsEva has completed recruiting patients for its Phase 3 clinical trial PRIMROSE 1 testing of oral gonadotropin releasing hormone (GnRH) receptor antagonist linzagolix for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

PRIMROSE 1 is being conducted at 117 sites, in the United States, randomizing approximately 500 patients with a diagnosis of HMB associated with UF, ObsEva noted in the press release Monday. It also said that a second Phase 3 clinical trial, PRIMROSE 2, is also being run in parallel in the U.S. and Europe— the trial is testing the same treatment arms at 102 sites where approximately 500 patients have also been randomized.

Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva, pointed out that Linzagolix is the only GnRH receptor antagonist developed in UF with a dosing option without concomitant administration of ABT to achieve sustained symptom relief and one with concomitant ABT administration.

“We expect to report six-month primary endpoint data from the PRIMROSE 2 and PRIMROSE 1 trials in the fourth quarter of 2019 and in the first half of 2020, respectively,” said Loumaye.