Intra-Cellular expects Caplyta to generate $665m-$685m in sales this year. Image credit: Lightspring / Shutterstock.

Having raised the full-year sales guidance for Caplyta (lumateperone) a week ago, Intra-Cellular Therapeutics has reported positive topline data from a Phase III trial of the therapy for prevention in relapse in schizophrenia patients.

The Study 304 (NCT04959032) trial met its primary endpoint of time to relapse during the 26-week double-blind treatment phase, with Caplyta treatment associated with a 63% reduction in the risk of relapse compared to the placebo.

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Caplyta is Intra-Cellular’s only marketed therapy. Last year, the drug generated $462.2m in sales, and the company expects net product sales for Caplyta this year to be between $665m and $685m, as per the company’s financials. GlobalData expects therapy sales to maintain an upward trajectory and generate over $3bn in sales by 2030.

GlobalData is the parent company of Clinical Trials Arena.

The multi-centre, parallel-group Phase III study enrolled 228 patients. All participants were treated with 42mg Caplyta in an 18-week open-label period before being randomised to receive either Caplyta or placebo as part of the double-blind treatment phase. The time to relapse was significantly longer in the Caplyta group compared to the placebo group, the study’s primary endpoint.

The rate of relapse was lower at 16.4% in the treatment group compared to 38.6% in the placebo group. The trial also met its secondary endpoint, with Caplyta treatment being linked with better treatment discontinuation rates during the double-blind phase.

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Caplyta is a butyrophenone antipsychotic. It was first approved by the US Food and Drug Administration (FDA) as a treatment for adults with schizophrenia in 2019. In 2022, the US regulatory agency expanded Caplyta’s approval to include treatment of depressive episodes associated with bipolar I or II disorder.

“The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes. We are very pleased that the results from Study 304, a randomised withdrawal trial, demonstrated efficacy along with favourable safety and tolerability which support the benefit of continued long-term treatment with Caplyta” said Dr Suresh Durgam, executive VP and chief medical officer at Intra-Cellular Therapies.

Intra-Cellular intends to expand Caplyta’s label in the US. The company plans to file for a supplemental new drug application (sNDA) with the FDA for Caplyta as an adjunct treatment for major depressive disorder (MDD) in Q4 2024.

Intra-Cellular is also evaluating the therapy in paediatric patients with schizophrenia and bipolar disorders in a Phase III trial (NCT06229210). The open-label study is currently recruiting participants and is expected to enrol about 500 patients under 18 years of age.