ObsEva Starts Long-term Follow-Up Study To Evaluate Bone Mineral Density After Yselty Treatment

ObsEva SA OBSV has initiated the observational PRIMROSE 3 study to evaluate long-term bone mineral density (BMD) in subjects who completed at least 20 weeks of linzagolix treatment in Phase 3 PRIMROSE 1 (U.S. only) and PRIMROSE 2 (Europe and E.U.) studies.
PRIMROSE 3 is a long-term follow-up study of PRIMROSE 1 and 2 patients across all dosing regimens of Yselty (linzagolix) - 100 mg or 200 mg daily, alone or with add-back therapy (ABT), as well as placebo recipients.
Of the 405 women who met the criteria, it is expected that over 300 will enroll.
Patients will be evaluated via a DXA scan of the femoral neck, hip, and spine at 12, 18, and 24 months. I
In addition, ObsEva will collect information on patients' menopausal status, physical activity, intercurrent medical conditions, and other factors that may affect bone mineral density.
Study participants will be recommended to use calcium and Vitamin D supplementation.
Yselty (linzagolix) is an oral GnRH receptor antagonist and is currently in late-stage development for heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.
ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia.
Price Action: OBSV shares are down 0.32% at $3.09 in premarket on the last check Tuesday.