FDA Approves Neuren’s NNZ-2591 for Prader-Willi Syndrome Study

FDA approves IND for Prader-Willi syndrome study of Neuren’s NNZ-2591

The European Medicines Agency (EMA) has approved the IND for a study of Neuren’s NNZ-2591, a novel treatment for Prader-Willi syndrome (PWS). This study is being conducted by NantHealth Therapeutics and will be conducted in a Phase III clinical trial.

The study will include 300 patients with PWS who will be randomly allocated to receive either the Neuren’s NNZ-2591 treatment regimen, or a placebo. The study will assess the safety, tolerability and potential efficacy of the Neuren’s NNZ-2591 treatment regimen.

This is the first IND approved for Prader-Willi syndrome and it is hoped that the Neuren’s NNZ-2591 treatment regimen will be the first to provide significant relief for patients with PWS. The study is expected to be completed in 2022.