ObsEva SA Completes Patient Recruitment in Phase 3 Fibroid Trial

ObsEva SA (NASDAQ: OBSV), a clinical- stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported completion of patient recruitment of its Phase 3 clinical trial PRIMROSE 2 evaluating oral gonadotropin releasing hormone (GnRH) receptor antagonist OBE2109 for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

PRIMROSE 2 is being conducted at 102 sites, in the United States and Europe, randomizing approximately 500 patients with a diagnosis of HMB associated with UF. Eligible patients are receiving once daily either 100 mg or 200 mg of linzagolix or placebo. Active treatment arms are being tested with and without low doses of hormonal add-back therapy (ABT). Patients are treated for up to 52 weeks to evaluate the safety of long-term treatment.

“We are evaluating long term administration of linzagolix in two dosing regimens: primarily, we are assessing the efficacy of a lower-dose of linzagolix without add-back therapy, and of a higher dose option in association with add-back therapy for patients requiring higher levels of estrogen suppression. This strategy will potentially allow us to offer the broad patient population the personalized options needed for symptom relief with fewer side effects” said Ernest Loumaye, Chief Executive Officer and Co-Founder of ObsEva. “Patient recruitment completion is an important step in this pivotal trial for the lead indication of linzagolix, a potential best-in-class oral GnRH antagonist. We anticipate the primary endpoint read out of PRIMROSE 2 in Q4 2019, in line with our development plan.”

https://www.marketscreener.com/news/ObsEva-SA-Announces-Completion-of-Patient-Recruitment-in-PRIMROSE-2-Phase-3-Clinical-Trial-of-Linzag–27785126/