According to Levo Therapeutics, the Phase 3 CARE-PWS (CARbetocin Efficacy and Safety Study in PWS) trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) has begun to enroll patients. Levo acquired the rights to the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and announced in June 2018 that it planned to restart the development program.
The study will first compare the effectiveness of LV-101 to placebo for the reduction of extreme hunger (hyperphagia), anxiety, and obsessive/compulsive symptoms over an 8 week period. After the initial portion of the study, patients who had been randomized to LV-101 will continue on LV-101, and patients who had been randomized to placebo will be randomized to one of two doses of LV-101 for the next portion of the trial, which will continue for 56 weeks.
Levo Therapeutics CEO Sara Cotter commented, “We are excited to bring intranasal carbetocin back into the clinic following the successful Phase 2 study. Levo is committed to developing impactful treatments for patients with PWS, and our initiation of this Phase 3 study is an important step towards this goal.”
Read the Levo Therapeutics press release.
