Johnson & Johnson reports positive Phase 3 Caplyta data

Johnson & Johnson announced positive topline results from the pivotal Phase 3 Study 451 evaluating Caplyta (lumateperone) for manic episodes in adults with bipolar I disorder. The trial met its primary endpoint, showing a statistically significant and rapid reduction in manic symptoms versus placebo at Week 3.

In the randomized, double-blind trial testing once-daily Caplyta 42 mg, patients experienced a 4.8-point greater reduction in the Young Mania Rating Scale total score compared to placebo at Week 3 (p<.0001). Significant improvement was observed as early as Day 3. In addition, 45.8% of patients receiving Caplyta achieved a clinical response, defined as at least a 50% score reduction, compared to 20.9% for placebo.

On key secondary measures, Caplyta showed a statistically significant improvement in overall illness severity on the Clinical Global Impression–Severity score, with a least-squares mean difference of –0.5 (p<.0001). The most common adverse events occurring at 5% or more and at twice the placebo rate were dry mouth (7.9% vs. 3.4%) and nausea (7.9% vs. 2.3%).

Caplyta is not currently approved for manic episodes associated with bipolar I disorder. Johnson & Johnson stated that data analysis is underway for a second completed pivotal Phase 3 trial, Study 452.