These data build upon previous topline results announced in January 2022.
ObsEva recently announced positive efficacy results from its phase 3 clinical trial EDELWEISS 3 (NCT03992846) trial of linzagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, in women with moderate to severe endometriosis-associated pain (EAP). These data build upon previous topline results announced in January 2022, according to a company press release.1
The study, a randomized, double-blind, placebo-controlled trial, evaluated the long-term efficacy and safety of linzagolix in 484 women with moderate to severe EAP. Investigators evaluated 2 dose regimens: linzagolix 200 mg once-daily in combination with hormonal add-back therapy (ABT) and linzagolix 75 mg without ABT. Co-primary endpoints included a reduction in dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) at 3 months.
Results demonstrated rapid reductions in DYS and NMPP compared to placebo (following 1 and 2 months of treatment, respectively), as well as sustained reduction up to 6 months of treatment. Additionally, linzagolix 200 mg and ABT demonstrated higher reductions compared to linzagolix 75 mg.
Similar results were observed for the secondary endpoints of dyschezia and worst pelvic pain (5 days with worst pain during a 28-day period). Quality of life improvements were also associated with reduction in endometriosis pain, as well as a reduction in physician and patient intentions to undergo surgery for endometriosis after 6 months.
“Endometriosis is a common and painful condition that affects approximately 10 percent of women of reproductive age. Every day it seriously impacts women’s ability to go about their daily activities, their relationships, and their overall quality of life,” said Hugh Taylor, MD, professor and chair of Obstetrics and Gynecology at Yale University. “These data build on the positive data announced earlier this year and importantly support the early onset of efficacy with linzagolix treatment.”
Post-treatment follow-up results are expected in Q3 of 2022 and results from the treatment phase of the extension study EDELWEISS 6 (NCT04335591) and its post-treatment follow-up are expected in early Q3 and Q4, according to ObsEva.
“We are pleased with these additional EDELWEISS study results, which demonstrate the rapid onset of treatment effect, impact on quality of life and intentions for surgery, and continue to support the promising clinical profile of linzagolix in the treatment of women with moderate-to-severe endometriosis-associated pain,” said Elizabeth Garner, MD, MPH, chief medical officer of ObsEva. “We look forward to advancing the endometriosis program for linzagolix, which will include exploration of a non-add back therapy option, consistent with our strategy to address the individual treatment needs and preferences of all women.”
1. ObsEva Announces Additional Efficacy Results for Linzagolix 200 Mg with Add-Back Therapy (ABT) and Linzagolix 75 Mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain. Obseva; 2022. Accessed March 25, 2022. https://www.obseva.com/pressrelease-detail/