Positive Phase III Outcomes for Caplyta in Treating Major Depression

Intra-Cellular Therapies aims to expand the use of its antipsychotic drug Caplyta (lumateperone), having released promising Phase III trial results for major depressive disorder (MDD). Following the announcement, the company’s stock surged by 20%.

The clinical study showed that when Caplyta was used alongside patients' existing antidepressants, it significantly improved Montgomery-Åsberg Depression Rating Scale (MADRS) scores, lowering them by 4.9 points compared to the placebo after six weeks. The trial included 500 patients split between the Caplyta and placebo groups, with initial efficacy apparent within the first week and sustained throughout the study.

Mizuho Securities’ managing director, Graig Suvannevejh, highlighted the results in a note to investors, indicating that the outcomes surpassed initial expectations of a two to four-point improvement in MADRS scores. Suvannevejh also mentioned the potential for further stock growth, considering the MDD market is expected to reach $9.6 billion by 2029.

Sharon Mates, CEO of Intra-Cellular Therapies, emphasized the strong efficacy, favorable safety profile, and convenient dosing of Caplyta, suggesting it could become a significant adjunctive treatment for MDD if approved. The drug is currently undergoing another Phase III trial, with topline results expected in the second quarter of the year.

Caplyta, which has been the flagship product for Intra-Cellular Therapies, is already approved for treating schizophrenia and depressive episodes in bipolar I or II disorder. Its popularity has surged, with 2023 sales reaching $462 million — an 86% increase from the previous year.

In March 2024, Intra-Cellular Therapies initiated a patent infringement litigation against seven companies seeking to introduce generic versions of Caplyta. Suvannevejh believes that the drug will maintain its market exclusivity until 2036 based on the analysis of the intellectual property case.

Overall, the latest developments for Caplyta underscore its potential in treating major depressive disorder, a market that is steadily growing. The positive data from the recent trial augments its standing in the therapeutic field, positioning Intra-Cellular Therapies for further success.