Intra-Cellular Therapies (NASDAQ:ITCI) soars 74% premarket in reaction to positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.
In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (p=0.0206; effect size = 0.27).
In the intent-to-treat study population, the mean reduction from baseline for lumateperone 42 mg was 16.9 points, versus 14.5 points for placebo (LS mean difference = 2.4 points; effect size = 0.27, p=0.0206).
Key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Bipolar for Severity of Illness – Depression subscale (CGI-BP-S Depression Score) (p=0.0082; effect size = 0.31) was also achieved.
The lower lumateperone dose, 28 mg, showed a trend for a dose-related improvement in symptoms of depression but the results did not reach statistical significance.
Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial.
This trial, in conjunction with previous Phase 3 monotherapy study, Study 404, forms the basis for sNDA submission to the FDA in late 2020 or early 2021.
A total of 529 patients were enrolled in Study 402.
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