Phase 3 Trials of Linzagolix for Endometriosis on Hold Amid COVID-19 Pandemic

Phase 3 Trials of Linzagolix for Endometriosis on Hold Amid COVID-19 Pandemic

Due to the COVID-19 pandemic, ObsEva has put on hold its key Phase 3 clinical trials, confirming the safety and efficacy of linzagolix, an experimental oral therapy intended to alleviate pain related to endometriosis.

“Our top priority is the safety of all the women who are participating in our clinical trials, as well as the health and safety of our employees and the healthcare professionals and external partners conducting our trials,” Ernest Loumaye, MD, PhD, CEO and co-founder of ObsEva, said in a press release.

“Today we are instituting new measures to support these priorities as we all work together to safely manage through the Covid-19 pandemic,” Loumaye added.

The two Phase 3 trials, EDELWEISS 2 (NCT03986944) currently underway in the U.S., and EDELWEISS 3 (NCT03992846), in the U.S. and EU, are expected to enroll approximately 900 women with endometriosis.

Both studies were designed to assess the safety and efficacy of linzagolix at managing moderate to severe pain associated with endometriosis, compared with a placebo. Linzagolix will be given orally at a dose of 75 mg by itself, or 200 mg n combination with low-dose hormone replacement therapy.

Now, as a preventive measure to ensure participants’ safety, patient screening and randomization have been put on hold in both trials due to the COVID-19 pandemic. Moreover, additional safety measures have been implemented at clinical sites to ensure the safety of all randomized patients already receiving treatment as part of these trials.

According to ObsEva, the company will continue to monitor the COVID-19 situation on a daily basis, and is ready to take further action as needed. The company plans to resume patient screening and randomization in the two trials as soon as the situation allows it.

In the meantime, ObsEva remains on track to announce findings from the PRIMROSE 1 (NCT03070899) and PRIMROSE 2 (NCT03070951) testing linzagolix in uterine fibroids, and PROLONG (NCT03369262) for OBE022, its new treatment for preterm labor.

The company also evaluated the impact of the COVID-19 pandemic on its financial situation. With a recent staff reduction and delayed spending on the EDELWEISS trials, ObsEva expects to have funds to sustain its operating expenses until late 2021.