Intra-Cellular Therapies edges closer to FDA win for Caplyta in depression

 Intra-Cellular Therapies has secured another win with positive topline results from a Phase III study evaluating Caplyta (lumateperone) as an adjunctive therapy in patients with major depressive disorder (MDD).

In the trial, dubbed Study 502 (NCT05061706), a 42mg daily dose of Caplyta (lumateperone) as an adjunctive therapy provided a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) at week 6 compared to placebo, meaning the trial met its primary endpoint.

The drug also met the key secondary endpoint of change from baseline on the Clinical Global Impression Scale for Severity of Illness (CGI-S) at week 6.

The study randomised 480 subjects to receive 42mg Caplyta plus an antidepressant, or placebo plus an antidepressant to evaluate the efficacy and safety of the drug as an adjunctive treatment to antidepressants for patients with MDD.

Intra-Cellular’s share price leaped by 10.5% following the news.

Intra-Cellular has said that data from this trial along with that from the previously reported Phase III Study 501 (NCT04985942), forms the basis of a supplemental NDA (sNDA) submission for Caplyta as an adjunctive treatment for MDD. The submission is expected in the second half of 2024. Data from Study 501, which recruited 485 patients, showed a 4.9-point reduction in MADRS compared to placebo.

The MDD market is a competitive one with[MV1] several different players. The US Food and Drug Administration (FDA) approved AbbVie’s Vraylar (cariprazine) as an adjunctive treatment to antidepressants to treat adult patients with MDD in 2022. Vraylar generated $2.8bn in sales for AbbVie last year, as per the company financials.

Caplyta, a butyrophenone antipsychotic agent, is already indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder, as both a monotherapy and an adjunctive therapy with lithium or valproate. According to GlobalData’s Pharma Intelligence Center, Caplyta is forecast to generate nearly $3bn in 2030, an increase from $918m in 2025.

GlobalData is the parent company of Clinical Trials Arena.

Sharon Mates, Intra-Cellular’s CEO said: “We are confident that the efficacy results from Studies 501 and 502, along with the favourable safety and tolerability profiles from these studies, will make lumateperone a drug of choice for patients suffering with MDD who are having an inadequate response to antidepressant therapy."

https://finance.yahoo.com/m/18356314-38b7-32ce-9e3b-572f5e85350a/intra-cellular-therapies.html