Minerva Neurosciences Screens First Patient in 380-Patient Phase 3 Trial with Topline Data Due 2H 2027
Minerva Neurosciences has screened the first patient in its global Phase 3 trial evaluating 64 mg roluperidone for negative symptoms of schizophrenia, enrolling roughly 380 adults across 40 sites. Topline efficacy data are expected in the second half of 2027 following two prior pivotal trials that showed consistent improvements.
1. Trial Initiation
The global Phase 3 MIN-101C19 trial has begun screening its first adult patient, targeting enrollment of approximately 380 participants aged 18–55 with moderate to severe negative symptoms of schizophrenia across around 40 clinical sites in the US and Europe.
2. Study Design
The trial features a two-part, randomized, double-blind design: a 12-week Phase A comparing 64 mg roluperidone to placebo for change in the PANSS Marder Negative Symptoms Factor Score and a 40-week Phase B active-controlled extension against risperidone, aripiprazole or olanzapine to assess positive symptom relapse rates.
3. Prior Trial Success
This confirmatory study builds on positive outcomes from Phase 2b and Phase 3 C07 trials, both of which demonstrated consistent improvements in negative symptoms at the 64 mg dose, de-risking roluperidone as the only late-stage candidate addressing this unmet need.
4. Timeline and Next Steps
Topline efficacy results for the primary 12-week Phase A endpoint are expected in the second half of 2027, with secondary analyses of personal and social performance and longer-term relapse data to follow as part of the 52-week study protocol.