ObsEva CEO Ernest Loumaye s said the instituting new measures to support the priorities of safety to manage through the COVID-19 pandemic.
ObsEva is working diligently with clinical sites, following regulatory, ethics committee, and health agency guidance related to the COVID-19 pandemic, to ensure the safety of employees and women participating in its clinical trials, it said in a press release Monday. Accordingly, the company has assessed its ongoing clinical trials and evaluated potential approaches to enhance safety measures. Immediate action has been taken, including the implementation of a recommendation to conduct remote patient visits
At present, PRIMROSE 1 and PRIMROSE 2 trial results remain on track to be announced in the second quarter of this year, as previously planned. PRIMROSE 1 and PRIMROSE 2 are Phase 3 clinical trials of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids, the comapny said. Furthermore, both trials have completed the enrollment of approximately 500 women. In addition, the company continues to expect PROLONG trial results will be reported in the second half of 2020, as previously planned. PROLONG is the Phase 2a trial of OBE022 for the treatment of preterm labor at weeks 24-34 of gestation.
EDELWEISS 2 and 3 are ObsEva’s ongoing Phase 3 trials of linzagolix for the treatment of pain associated with endometriosis. In view of the expected logistical challenges with initial screening and uncertainty about continuity of treatment for randomized patients because of the COVID-19 pandemic, ObsEva has decided to place a voluntary hold on further screening and randomization of patients into these two trials until further notice. Clinical trial sites will be managing all randomized patients currently on treatment to proceed with enhanced safety measures and the trial protocol whenever feasible.
“ObsEva remains ready and committed to resume patient screening and randomization as the situation permits. Given the dynamic nature of the COVID-19 pandemic, ObsEva will continue to monitor its operations on a daily basis and will assess the need for further actions as appropriate,” the company said.
ObsEva has also assessed the impact of COVID-19 on its financial position. ObsEva is continuing to manage its expenses, including through a recent reduction in staff and employee benefits and delayed spending on EDELWEISS 2 and EDELWEISS 3.
As of December 31, 2019, ObsEva had $69.4 million of cash and cash equivalents. With existing cash and cash equivalents together with amounts available to ObsEva to borrow under its credit facility and the aforementioned expense reductions, the Company expects to fund its operating expenses into the third quarter of 2021.