Johnson & Johnson (NYSE:JNJ) on Monday reported topline results from its Phase 3 study evaluating Caplyta (lumateperone) for adults experiencing manic episodes linked to bipolar I disorder. The trial successfully met its primary endpoint, demonstrating a statistically significant and rapid reduction in manic symptoms compared to placebo at Week 3, with noticeable improvements appearing as early as Day 3.
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“These results are encouraging because CAPLYTA not only significantly improved the symptoms of mania, but did so as early as Day 3, with benefits sustained through Week 3, supporting its potential to meaningfully advance how we treat acute mania in bipolar I disorder,” said Michael Thase, a professor at the University of Pennsylvania. Phase 3 Study Delivers Rapid Symptom Reduction The study evaluated once-daily 42mg Caplyta against placebo over a three-week duration in patients with manic episodes, with or without mixed features.
8-point greater reduction in Young Mania Rating Scale total scores compared to placebo at Week 3, maintaining these gains from Day 3 onward. Bipolar disorder affects an estimated 37 million people globally, with acute manic symptoms frequently escalating and leading to hospitalization.
Read Also: Johnson & Johnson Says Lung Cancer Drug Shows Reduced Side Effects and Longer Patient Survival Secondary Outcomes and Clinical Response Rates Caplyta also delivered statistically significant improvements across key secondary measures. On the Clinical Global Impression–Severity scale, treated participants showed enhanced overall illness severity reductions compared to placebo.
9% of placebo subjects. See More: Top Momentum Stocks Safety Profile and Ongoing Research The therapy demonstrated favorable tolerability with low discontinuation rates, matching its established safety profile.
A second pivotal Phase 3 study (Study 452) evaluating Caplyta for the treatment of manic episodes in adults with bipolar I disorder has been completed, and data analysis is underway. 79 at the time of publication on Monday, according to Benzinga Pro data.
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