Minerva Neurosciences Inc (NASDAQ:NERV) received the official meeting minutes from the Type C meeting with the FDA regarding the development of roluperidone for negative symptoms in schizophrenia.
- The agency cited concerns related to the applicability of the results of the Phase 2b study (conducted in Europe) to the US population.
- The agency raised concern regarding the proposed use of post hoc analyses for the primary endpoint results of the Phase 3 study.
- Even by excluding one trial site that Minerva believes to be subject to potential data integrity issues, the overall study remains negative.
- For the Phase 3 study to be positive, both roluperidone doses must be statistically significant versus placebo, which was not the case for the 32 mg dose, the agency noted.
- Related: Minerva Posts Positive Bioequivalence Results For Schizophrenia Candidate Formulations.
- Excluding the trial site with data integrity issues resulted in a nominal p-value of 0.044 on the primary endpoint for the 64 mg dose. In the Phase 2b study, the 64 mg and the 32 mg doses of roluperidone achieved statistical significance versus placebo.
- Minerva stated that the relapse rate in these trials was less than 15% of the treated population compared to over 25% in other trials in which patients were treated with antipsychotics.
- The FDA advised that additional data collection could begin in parallel with Minerva's preparations for a potential marketing application.
- Price Action: NERV shares are up 3.02% at $0.89 during the market session on the last check Thursday.
