Eltoprazine: Updated Phase IIa data

An updated analysis of a double-blind, U.S. Phase Ila trial in 47 adult ADHD patients showed that 5 and 10 mg oral eltoprazine each met the primary endpoint of improving ADHD-RS-IV total score from baseline vs. placebo (17.9 and 17.4 points, respectively, vs. 13.6 points, p=0.003 and p=0.037). Low- and high-dose eltoprazine also significantly improved ADHD-RS-IV inattention subscale scores vs. placebo (p=0.003 and p=0.039, respectively). Additionally, low-dose eltoprazine significantly improved ADHD-RS-IV hyperactivity subscale scores vs. placebo (p=0.008). Neither eltoprazine dose significantly improved ADHD-RS-IV impulsivity subscale scores.

On secondary endpoints, low- and high-dose eltoprazine significantly improved CGI-I scores vs. placebo (p=0.023 and p=0.004, respectively). Additionally, the proportion of patients considered improved by investigator was 68.4% for low-dose eltoprazine (p=0.342) and 81.1% for high-dose eltoprazine (p=0.029) vs. 57.9% for placebo. On the POMS scale compared to placebo, low-dose eltoprazine significantly improved total score (p=0.006) and tension anxiety score (p=0.046) and both doses significantly improved anger-hostility score (p<0.001 and p=0.036, respectively). On the BAS scale for restlessness compared to placebo, low-and high-dose eltoprazine significantly improved total score (p=0.029 and p=0.007, respectively) and awareness of restlessness subscore (p=0.003 and p<0.001, respectively), and high-dose eltoprazine significantly improved distress related restlessness subscore (p=0.047). High-dose eltoprazine also significantly improved AIMS score vs. placebo (p<0.001). There were no serious adverse events, 2 severe treatment-related adverse events of hypnagogic hallucination and constipation with low-dose eltoprazine and 1 severe treatment-related adverse event of fatigue with high-dose eltoprazine. Amarantus said it has initiated a strategic review of the ADHD program. ...