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Intra-Cellular builds case for depression drug with late-stage trial win

An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.

The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.

More specifically, patients in the drug arm showed an average reduction of 14.7 points on a well-known, 60-point scale that clinicians use to gauge the severity of depressive symptoms. The control arm, meanwhile, had a reduction of 9.8 points. At the beginning of the study, both groups scored at or just above 30 points.

According to Intra-Cellular, researchers observed the drug — which is known scientifically as lumateperone and commercially as Caplyta — having a significant effect both in the first week of testing and throughout the main study period.

It was also generally safe and well-tolerated, with the most common adverse events being dry mouth, fatigue and tremors. Intra-Cellular said these events were mostly mild to moderate, resolved within a short period of time, and were similar to those seen in earlier studies testing the drug in people with schizophrenia or bipolar depression. The Food and Drug Administration approved Caplyta as a treatment for those conditions in 2019 and 2021, respectively.

The results were well-received on Wall Street. In notes to clients, Jefferies analyst Andrew Tsai wrote that “Caplyta is becoming a pipeline-in-a-pill,” while Mizuho Securities analyst Graig Suvannavejh noted how his team is “very pleased with the data.”

To Brian Abrahams of RBC Capital Markets, the findings are a “clear win” and “surpass even optimistic expectations.” Investors appear to agree, as shares of Intra-Cellular were up about 25% Tuesday morning, to trade at $81 apiece.

“We see the robust results as setting [Intra-Cellular] up well for a future regulatory path,” Abrahams wrote in his own note. The RBC team has predicted that sales of Caplyta in major depression could eventually reach $1.3 billion in the U.S.

Last year, Intra-Cellular recorded $462 million in net product sales from Caplyta.

Results from a second late-stage study are expected toward the end of June. If positive, they’ll further support Intra-Cellular’s bid to expand into major depression, a much larger market than schizophrenia and bipolar depression. In 2021, an estimated 21 million adults in the U.S. had at least one major depressive episode, according to the National Institutes of Mental Health.

Major depressive disorder is a “highly prevalent condition and there is a need for efficacious treatments with favorable safety and tolerability profiles given the majority of patients do not benefit from their initial therapy or suffer from side effects associated with existing therapies,” said Suresh Durgam, Intra-Cellular’s chief medical officer, in a statement.

“This study contributes to the growing body of evidence of lumateperone’s efficacy and safety across mood disorders,” Durgam added.

A third late-stage study evaluating the drug in major depression is set to produce data in October 2025.

In March 2023, Intra-Cellular disclosed positive data from a Phase 3 study that initially focused on bipolar depression but was amended to also include certain patients with major depressive disorder. That study also found participants who took Caplyta once a day for six weeks experienced significant reductions on that well-known scale for depression symptoms.