Intra-Cellular Therapies has nailed a second Phase 3 study testing its antipsychotic medication Caplyta as an adjunctive treatment for major depression.
Next, it plans to go to the FDA in the second half of this year to get the indication added to the drug’s label.
In the study results shared Tuesday, patients either got a 42 mg dose of Caplyta in conjunction with antidepressants, or a placebo plus antidepressants. Patients on Caplyta had a 14.7-point reduction on a widely used assessment called the Montgomery-Asberg Depression Rating Scale (MADRS). Placebo patients only improved by 10.2 points. The results were statistically significant, the biotech reported.
Patients started to show improvement just a few weeks into treatment. Most of the reported adverse events were mild to moderate, and the most common included dizziness, drowsiness and dry mouth.
Analysts lauded the performance, with Andrew Tsai at Jefferies writing that Intra-Cellular’s story “seems fairly derisked.” Mizuho analysts said the data were “better than our expectations.”
“We continue to see a differentiated profile for Caplyta relative to other antipsychotics in” major depressive disorder, Tsai wrote. Intra-Cellular’s shares $ITCI were up roughly 11% on Tuesday.
Sharon MatesCEO Sharon Mates said the company was “working away furiously” to get the supplemental package submitted, and anticipated that a launch could happen as soon as the second half of 2025. The drug is already approved to treat schizophrenia and bipolar depression.
The new results were the second round of positive Phase 3 data reported in as many months, after Intra-Cellular touted a successful first readout in April. That first study also examined patients with “mixed features,” defined as patients experiencing manic or hypomanic symptoms during a major depressive episode. Mates told investors that the company was still assessing how mixed features “might fit” in Caplyta’s addressable market.
Mates said the company’s sales team will be expanded in the months leading up to the launch and voiced confidence that Intra-Cellular could compete against AbbVie and its own depression drug, Vraylar. Jefferies estimates that entering the MDD market could be a $1 billion-plus opportunity for Caplyta.
“As long as we can maintain our share of voice, we think the product speaks for itself and can do extremely well in the marketplace,” Mates said on an investor call Tuesday.
As part of Tuesday’s readout, Intra-Cellular also reported a statistically significant improvement on scores in a second assessment, the Clinical Global Impressions-Severity (CGI-S) scale. That score is based on the clinician’s assessment of a patient’s mental health at a specific point in time.