ITCI - Intra-Cellular jumps 14% after early data for depression candidate

2023-03-28 08:43:59 ET

Intra-Cellular Therapies ( NASDAQ: ITCI ) added ~14% on Tuesday in the pre-market trading after announcing that its depression candidate lumateperone reached the key goals in a trial for patients with depressive episodes.

Study 403 was a randomized, placebo-controlled global trial designed to evaluate lumateperone 42mg as monotherapy in patients with major depressive episodes linked to major depressive disorder (MDD) or bipolar disorder.

According to its topline data, once daily lumateperone met the primary endpoint indicating a statistically significant and clinically meaningful decline of symptoms based on a clinical score calculated using the Montgomery Asberg Depression Rating Scale (MADRS).

The group of 192 patients in the lumateperone arm also met the key secondary endpoint, as there was a statistically significant and clinically meaningful reduction in overall disease severity based on the Global Impression of Severity Scale (CGI-S).

As for tolerability, the study drug was safe and well tolerated indicating a side effect profile in line with previous lumateperone studies, the company said.

“This study provides proof of concept in these patient populations and further validates lumateperone’s broad potential in mood disorders,” Chief Executive of Intra-Cellular ( ITCI ) Dr. Sharon Mates said.

The company intends to discuss the results with the FDA to decide on the next steps for the program.

Lumateperone, under the brand name Caplyta, is indicated in the U.S. for schizophrenia and bipolar depression. Seeking Alpha analyst Stephen Ayers argues, "Caplyta is on track to become a blockbuster drug in the near future.”

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