Intra-Cellular Touts Phase III Major Depressive Disorder Results for Antipsychotic Drug

Mental Health/iStock, BlackSalmon

Pictured: An artists illustration of mental health concept/iStock, BlackSalmon

Intra-Cellular Therapies hopes to add another indication to its antipsychotic drug Caplyta (lumateperone), reporting positive Phase III data in major depressive disorder. The biopharma company’s stock shot up 20% Tuesday morning on the news. 

Caplyta, given in addition to a patient’s antidepressants, significantly reduced patients Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo by 4.9 points at week six, according to Intra-Cellular Therapies (ICT). Five hundred patients were enrolled in the study across the Caplyta and placebo cohorts. The earliest point of testing at one week of treatment already showed efficacy, which was maintained through the study, the company said.  

Study results are better than expected, Mizuho Securities managing director Graig Suvannevejh said in a note to investors on Tuesday. ICT had previously stated expectations of a potential improvement of two to four points. While the company’s stock is already up 20% on the news, there’s potential for it to move even higher,  Suvannevejh added. The major depressive disorder (MDD) market is projected to grow to $9.6 billion by 2029. 

“We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make Caplyta  a compelling option as an adjunctive treatment for MDD, if approved,” Sharon Mates, CEO of Intra-Cellular Therapies, said in a statement. 

The drug is in an additional Phase III study anticipated to report topline results in the second quarter of this year.  

Caplyta is ICT’s first approved product, currently indicated for schizophrenia and depressive episodes associated with biopolar I or II disorder. The drug has been booming in popularity with 2023 sales coming in at $462 million, up 86% compared to the prior year.  

In March 2024, ICT filed a patent infringement litigation against seven generic drug manufacturers that had submitted abbreviated new drug applications to bring a Caplyta generic to the market. Suvannevejh said at the time in a note to investors that the research done on the intellectual property case for Caplyta leads him to believe loss of exclusivity for the product won’t occur until 2036. 

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn

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