Intra-Cellular strengthens Caplyta data with another Phase III success

Intra-Cellular Therapeutics recently announced promising results from a Phase III trial regarding their drug, Caplyta (lumateperone), aimed at preventing relapse in patients with schizophrenia. This announcement follows the company's recent increase in full-year sales projections for Caplyta, forecasting between $665 million and $685 million in sales for 2024. Last year, Caplyta generated $462.2 million in revenue, and projections by GlobalData suggest that sales could surpass $3 billion by 2030.

Study 304, listed under NCT04959032, was a comprehensive, multicenter, parallel-group Phase III trial, which included 228 participants. These patients were initially treated with 42 mg of Caplyta during an 18-week open-label period. Following this, they were randomly assigned to either continue with Caplyta or switch to a placebo during a 26-week double-blind treatment phase. The primary endpoint of the study was the time to relapse, where Caplyta treatment showed a significant 63% reduction in the risk of relapse in comparison to the placebo.

The relapse rate was notably lower in the Caplyta group, at 16.4%, compared to 38.6% in the placebo group. Additionally, the trial met its secondary endpoint, demonstrating that patients treated with Caplyta had better rates of treatment continuation during the double-blind phase. These results underline the effectiveness of Caplyta in maintaining symptom control and preventing relapses, which are crucial for the long-term management of schizophrenia.

Caplyta, a butyrophenone antipsychotic, received its initial approval from the US Food and Drug Administration (FDA) in 2019 for treating adults with schizophrenia. In 2022, the FDA extended its approval to include the treatment of depressive episodes related to bipolar I or II disorder.

Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer at Intra-Cellular Therapeutics, expressed satisfaction with the trial outcomes. He emphasized the importance of managing symptoms and preventing relapses for improving long-term patient outcomes. He noted that the findings from Study 304 reaffirm the benefits of sustained long-term treatment with Caplyta, highlighting its efficacy and favorable safety profile.

Looking ahead, Intra-Cellular Therapeutics aims to broaden Caplyta's usage in the United States. The company plans to submit a supplemental new drug application (sNDA) to the FDA in the fourth quarter of 2024, seeking approval for Caplyta as an adjunct treatment for major depressive disorder (MDD). Moreover, the company is conducting another Phase III trial (NCT06229210) to evaluate the efficacy of Caplyta in pediatric patients with schizophrenia and bipolar disorders. This ongoing open-label study aims to recruit approximately 500 patients under the age of 18.

Overall, these developments indicate Caplyta's significant potential in addressing a range of psychiatric conditions, reinforcing Intra-Cellular Therapeutics' commitment to advancing mental health treatment options.