ARTICLE | Clinical News

Encenicline: Additional Phase IIb data

August 10, 2015 7:00 AM UTC

Additional data from a double-blind, international Phase IIb trial in 317 schizophrenia patients with cognitive impairment on chronic stable second-generation antipsychotics showed that once-daily 0.27 and 0.9 mg doses of oral encenicline for 3 months improved mean CogState overall cognition index score, the primary endpoint, by 0.117 points (p=0.034) and 0.042 points (p=0.255) relative to placebo, respectively. On secondary endpoints, encenicline improved mean MCCB score -- measured only in the U.S. due to language availability -- from baseline to month 3 by 2.9 points in the low-dose arm and by 3.3 points in the high-dose arm vs. 1.2 points for placebo (p=0.142 and p=0.069, respectively). High-dose encenicline significantly improved SCoRS score from baseline to 3 months vs. placebo (p=0.011). Low-dose encenicline was non-significant on the SCoRS endpoint vs. placebo (p=0.7). There was no significant difference in the positive or general psychopathology subscales of the PANSS between treatment arms. Encenicline reduced mean score on the negative subscale of the PANSS from baseline to day 77 by 1.18 points in the low-dose arm (p=0.16) and by 1.44 points in the high-dose arm (p=0.028) vs. 0.71 points for placebo. Encenicline was well tolerated. Data were published in Neuropsychopharmacology. ...