Eoneren/E+ via Getty Images Intra-Cellular Therapies ( NASDAQ: ITCI ) traded higher in the premarket Tuesday after announcing that its FDA-approved mood disorder therapy lumateperone reached the main goal in a Phase 3 trial in combination with antidepressants. Citing topline data from Study 502, the New York-based developer of antipsychotics said that lumateperone at 42 mg succeeded as an adjunctive treatment to antidepressants in patients with major depressive disorder (MDD). Study 502, which, along with Intra-Cellular’s ( ITCI ) Study 501, forms the basis for a potential lumateperone label expansion, involved MDD patients who have had an inadequate response to anti-depressants.
The antipsychotic is currently marketed in the U.S. as Caplyta for schizophrenia and depressive episodes linked to bipolar disorder.
Lumateperone reached the primary endpoint in Study 502, leading to a statistically significant and clinically meaningful decline in a clinical measure called the Montgomery-Åsberg Depression Rating Scale at Week 6, Intra-Cellular ( ITCI ) said. According to the company, the experimental therapy was generally safe and well tolerated, with dizziness and dry mouth being some of the most common adverse events. Intra-Cellular ( ITCI ) also announced plans to submit a supplemental new drug application with the FDA in H2 2024, seeking a possible label expansion for lumateperone.
More on Intra-Cellular Therapies Intra-Cellular Therapies, Inc. (ITCI) Q1 2024 Earnings Call Tr.
