ObsEva: Linzagolix Phase 3 Trial Shows Positive Topline Results In Women With Moderate-to-severe EAP

ObsEva SA (OBSV), a Swiss biopharmaceutical company focused on women's health, announced Thursday positive topline results from the Phase 3 EDELWEISS 3 trial of linzagolix in women with moderate-to-severe endometriosis-associated pain or EAP.

Linzagolix is an oral GnRH antagonist. In the trial, two doses were tested, a 200 mg once-daily dose of linzagolix in combination with add-back therapy or ABT and a 75 mg dose of linzagolix without ABT.

The company said the results support continued development of linzagolix with ABT and non-ABT doses for the treatment of endometriosis.

The once daily linzagolix 200 mg dose met the co-primary efficacy objectives, demonstrating reductions in dysmenorrhea or DYS and non-menstrual pelvic pain or NMPP at 3 months.

The 75 mg dose without ABT demonstrated a statistically significant reduction versus placebo in DYS at 3 months.

Both linzagolix doses were generally well-tolerated with minimal BMD decrease and few adverse events occurring in more than 5% of patients up to 6 months.

Additional data from the post-treatment follow-up of EDELWEISS 3 are expected in the second quarter and from the post-treatment follow-up of the extension study in the fourth quarter.

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