The Company is actively enrolling patients in the pivotal Phase 3 trial with roluperidone (clinicaltrials.gov identifier: NCT03397134). Approximately 60 sites in the U.S. and Europe are participating in this trial, and target enrollment is approximately 500 patients. Completion of full enrollment is now expected in the second half of 2019, and top-line results from the 12-week, double-blind portion of the trial are expected in the fourth quarter of 2019.
In parallel with advancing its Phase 3 study, Minerva is continuing preparatory work for regulatory filing and commercialization. These activities include clinical pharmacology studies and manufacturing of registration batches.
Pre-clinical data presented at the 2019 Congress of the Schizophrenia International Research Society suggest a mechanistic role for roluperidone in addressing negative symptoms. Presenters also indicated the potential of roluperidone for disease modification and improved neuroplasticity