"at day
28, the efficacy measurements showed a clinically meaningful reduction in depressive and
cognitive symptoms across all measures for the two lower doses (40 mg/day and 80 mg/day) but
not for the highest dose (120 mg/day). These improvements appeared to persist over time during
the follow-up for MADRS, SDQ, and CPFQ. In terms of safety, no serious AEs occurred and the
drug was well tolerated. The main limitations of this study are the relatively small sample size of
each cohort and the fact that efficacy analyses were not the primary aim, and were meant to be
only descriptive in nature. In summary, a novel neurogenic compound, NSI-189, has shown
promise as a potential treatment for MDD in a Phase 1B, double-blind, randomized, placebocontrolled,
multiple-dose study with three ascending cohorts."
