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

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