Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded in 2014.
The Phase 2 study enrolled a total of 37 PWS patients aged 10-18. Results from the study published in JCI Insight show that the study met its primary endpoint, with statistically significant reductions in overeating (hyperphagia) in patients who received intranasal carbetocin compared to those who received a placebo. Multiple secondary endpoints related to other symptoms of PWS were also met.
Levo Therapeutics CEO Sara Cotter said, “Levo is excited that these data are now available to the PWS community, as they show the potential of LV-101 to treat this rare genetic syndrome. LV-101 showed meaningful improvements in all primary and secondary endpoints. Building on these promising data, we look forward to bringing intranasal carbetocin back into the clinic later this year.”
Read the Levo Therapeutics press release.
