Intra-Cellular rises again on Caplyta data in major depression disorder (MDD) | $ITCI
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) on June 18, 2024, said a second phase III study, nave Study 502, evaluating Caplyta (lumateperone) as a treatment for major depressive disorder (MDD) met the primary endpoint and a key secondary endpoint.
As an adjunctive therapy in MDD, Caplyta provided a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) at week 6 compared to placebo, satisfying the primary endpoint in Study 502, according to Intra-Cellular. The drug also met a secondary endpoint of change from baseline on the Clinical Global Impression Scale for Severity of Illness (CGI-S) at week 6.
In April 2024, Intra-Cellular reported positive results from Study 501. Both studies 501 and 502 are enrolled MDD adult patients who experienced an inadequate response to current antidepressant monotherapy (ADT). Caplyta already is approved to treat schizophrenia and bipolar depression. Intra-Cellular now plans to file an NDA for lumateperone to become an adjunctive therapy for MDD.
SanaCurrents issued a report on Intra-Cellular’s studies 501 and 502 in March 2024. At the time of the report, Intra-Cellular’s stock traded at $69.06 per share. The company’s stock closed on April 16 at $79.84 per share, a 15.6% gain from the time of the report. On June 18, the company’s stock closed at $78.53 per share, up from $68.87 per share at close on June 17.
