Intra-Cellular depression drug successful in late-stage trial

Intra-Cellular Therapies is working towards obtaining approval to market its drug, Caplyta, for the treatment of depression, following promising results from a second late-stage clinical trial. Currently, Caplyta, also known as lumateperone, is approved for treating schizophrenia and depressive episodes linked to bipolar disorder. The company now aims to broaden its application to include major depressive disorder.

The recent study involved 480 patients who were already receiving medication for depression. Those who were randomly assigned to receive Caplyta as an adjunct to their existing treatment showed significantly better outcomes on depression symptom scales compared to those who received a placebo. This positive result was announced by Intra-Cellular Therapies on Tuesday.

The implications of these findings are substantial for Intra-Cellular Therapies, as major depressive disorder affects approximately 21 million people annually in the United States. Current first-line treatments fail to fully address the condition in about two-thirds of patients, according to the company. If Caplyta gains approval for this new indication, analysts predict its sales could exceed $3 billion annually. RBC Capital Markets suggests the approval could potentially contribute an additional $1.7 billion in revenue. Andrew Tsai, an analyst at Jefferies, noted that Caplyta's launch for schizophrenia and bipolar depression has already been successful, with sales expected to peak at $2 billion annually.

The efficacy results from the recent study, known as study 502, closely mirror the impressive data from the earlier trial, study 501, according to RBC analyst Brian Abrahams. Both safety and tolerability were in line with previous research, indicating a clear path towards approval for Caplyta in the treatment of depression. Abrahams expressed confidence that the second study solidifies the case for expanding Caplyta's label to include major depressive disorder.

Intra-Cellular Therapies plans to submit an application to the Food and Drug Administration (FDA) in the latter half of this year to include the adjunctive treatment of major depressive disorder in Caplyta's label. If successful, this could lead to FDA approval for the new use by 2025.

This progress comes at a time when the pharmaceutical industry is increasingly focusing on psychiatric medications after a period of relative neglect. Last year, Bristol Myers Squibb agreed to acquire Karuna Therapeutics for $14 billion to gain access to an experimental drug for schizophrenia with significant market potential. Similarly, AbbVie acquired Cerevel Therapeutics in a multi-billion-dollar deal, highlighting the growing interest in psychiatric treatments.

In summary, Intra-Cellular Therapies is poised to expand the use of Caplyta to treat major depressive disorder following favorable outcomes in recent clinical trials. The potential approval could significantly enhance the company's market presence and address a substantial unmet need in the treatment of depression. The pharmaceutical industry's renewed interest in psychiatric drugs underscores the importance and potential profitability of such treatments.