ObsEva Starts Long-term Follow-Up Study To Evaluate Bone Mineral Density After Yselty Treatment
- ObsEva SA (NASDAQ: 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.
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