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.

https://finance.yahoo.com/m/65829a5c-5ec0-32e9-8a1d-48e877e868f2/intra-cellular-builds-case.html