Shares of the microcap biotech Minerva Neurosciences Inc (NASDAQ: NERV) were pulling back to their lowest level in a year Monday following the release of a clinical trial readout.
Minerva said a Phase 2b clinical trial that evaluated its seltorexant as adjunctive therapy to antidepressants showed statistically significant improvement in the Montgomery-Asberg Depression Rating Scale.
The drug was evaluated in adult patients with major depressive disorder who have responded inadequately to selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
"The least squares mean (LS mean) difference from placebo of the change in MADRS total score at the end of week 6 was 3.1 for the 20 mg dose of seltorexant, and the 2-sided p-value was 0.083, which is below the pre-specified 2-sided type I error level of 0.1," according to the biotech.
The pipeline asset is being co-developed with Johnson & Johnson (NYSE: JNJ)'s Janssen unit.
Minerva said a key secondary outcome, based on patient stratification according to baseline insomnia severity index, showed an even greater difference from the placebo in the seltorexant 20mg arm.
The 40mg arm, for which further enrollment was stopped earlier following an interim analysis, did not reach statistical significance. Because of the small sample size of patients assigned to the 10mg dose, the results from this arm were not interpretable, the company said.
Minerva said it did not identify any safety issues with seltorexant.
Minerva said top line results from a separate Phase 2b trial of seltorexant in insomnia are expected to be announced later this quarter.
Minerva shares were down 5.35 percent at $6.54 at the time of publication Monday.
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