Roluperidone phase 3 trial: primary endpoint missed in ITT (p=0.064) but significant in mITT; PSP improved

Minerva Neurosciences, Inc.

NSFS (primary) for roluperidone 64mg vs placebo: p≤0.064 (ITT), p≤0.044 (mITT).
PSP total score (key secondary) significantly improved for 64mg vs placebo: p≤0.021 (ITT), p≤0.017 (mITT).
Relapse rate during open-label extension: 6% (64mg) and 9% (32mg) over one year.
Trial enrolled 513 schizophrenia patients with moderate to severe negative symptoms; monotherapy design.
Results presented at ACNP meeting December 2021.

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