Shares of Intra-Cellular Therapies rocketed up Tuesday morning, after the New York-based biotechnology company unveiled positive clinical trial results for a depression medication that some analysts called a “clear win.”
The medication, known scientifically as lumateperone and commercially as Caplyta, has already received Food and Drug Administration approval to treat schizophrenia as well as the depressive episodes associated with multiple types of bipolar disorder. But Intra-Cellular has been trying to broaden the drug’s use, and in late 2020 amended a late-stage study that initially focused on just bipolar depression to also include patients with major depressive disorder.
The results released Tuesday pertain to roughly 380 study participants who have either major depressive disorder with “mixed features” — meaning that, when they experience mood episodes, they demonstrate both manic and depressive symptoms — or bipolar disorder with mixed features. The study ultimately found that participants who took lumateperone once a day for six weeks as opposed to a placebo had a significant reduction on a well-known scale used to measure the severity of depressive episodes.
Across the entire drug-treated group, scores fell 18.1 points, which was on average 5.7 points greater than what was observed in the control arm. And researchers saw similar differences when the results were separated by disease type.
Intra-Cellular said lumateperone met the trial’s secondary goal, too, by showing a statistically significant and clinically meaningful reduction on another scoring system used with psychiatric disorders.
The drug was also safe and well-tolerated, according to Intra-Cellular. The side effect profile was consistent with earlier lumateperone trials, and the most commonly reported adverse events that occurred at a higher rate in the drug arm were drowsiness, dizziness and nausea.
“We are very pleased with the results of this highly successful trial in these difficult to treat patient populations,” Sharon Mates, Intra-Cellular’s CEO, said in a statement, adding that the study “further validates lumateperone’s broad potential in mood disorders.”
“We look forward to discussing these results with the FDA and determining next steps for the program,” Mates said.
On Wall Street, the results proved better than expected. Jefferies analyst Andrew Tsai called them a “blue-sky scenario” in a note to clients, while Graig Suvannavejh of Mizuho Securities wrote that “the initial top-line data look clean on both efficacy and safety.”
"While the regulatory path is still unclear, we believe today's strong data will likely encourage the FDA to take a serious look at [Intra-Cellular’s] package to potentially expand the label for a formal mixed features indication,” wrote RBC Capital Markets analyst Brian Abrahams in a note to clients.
Abrahams and his team also classified the data as a “clear win” and estimated that the market opportunity for lumateperone could exceed $2.5 billion in annual sales, should it be used to treat both mixed features and adjunctive major depressive disorder.
In 2022, Intra-Cellular recorded $249 million in net sales from Caplyta, more than triple the total from the year prior.
Tuesday’s announcement lifted Intra-Cellular’s share price as much as 20%, to around $57.50, adding about $1 billion to the company’s market value.