Shares of Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) are presently undergoing a discernible ascent, marking a notable increase of 20.27% at the latest observation, reaching a value of $77.89. This significant surge in the pre-market valuation of ITCI shares seems to find its support in the recent disclosure of clinical development data.
Intra-Cellular (ITCI) has unveiled today affirmative top-line outcomes from Study 501, which assesses lumateperone 42 mg as a supplementary regimen to antidepressants for addressing major depressive disorder (MDD).
The top-line findings from its subsequent Phase 3 endeavor, Study 502, are anticipated to surface in the latter part of the second quarter of the current calendar. These favorable Phase 3 results concerning MDD mark a considerable advancement towards ITCI’s objective of firmly establishing CAPLYTA as a preferred therapeutic option spanning mood disorders.
Intra-Cellular contends that these robust efficacy findings, coupled with its favorable safety and tolerability profile, alongside convenient dosing, position CAPLYTA as a compelling adjunctive therapy for MDD, pending regulatory approval. ITCI is dedicated to enhancing treatment options for patients grappling with major neuropsychiatric disorders, evident in its endeavors to broaden CAPLYTA’s indication range and progress its pipeline.
Furthermore, lumateperone 42 mg has met the pivotal secondary endpoint in the investigation, manifesting a statistically notable and clinically substantial reduction in the CGI-S score relative to the placebo at Week 6. Significant effectiveness was noted for both the major and important secondary outcomes from the first assessed time point (Week 1) and was continuously maintained throughout the investigation.
This Phase 3 investigation highlights lumateperone’s strong adjunctive effect in light of the high prevalence of MDD and the critical need for effective treatments with favorable safety and tolerability profiles, particularly in light of the fact that the majority of patients either do not benefit from initial therapy or experience negative side effects from existing treatments.
Consequently, this study contributes to the burgeoning corpus of evidence delineating lumateperone’s efficacy and safety profile across a spectrum of mood disorders.
