Intra-Cellular Therapies’ Caplyta significantly improved symptoms in a late-stage major depressive disorder trial, marking a step in the drug’s journey to becoming a pipeline-in-a-pill.
Atypical antipsychotic Caplyta is already approved for schizophrenia and bipolar depression. According to Jefferies analysts, the drug is “becoming a pipeline-in-a-pill” and could reach $2 billion in peak sales in these two indications.
The Phase 3 trial tested Caplyta versus placebo as an adjunct to an antidepressant in 485 patients with major depressive disorder (MDD), per a Tuesday release.
The 42 mg treatment dose hit the primary endpoint, achieving a mean 4.9-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo at six weeks (p<0.0001). It also met the key secondary endpoint of change on the Clinical Global Impression Scale for Severity of Illness (p<0.0001).
Given that Intra-Cellular management had previously set a mean two-to-four point improvement in MADRS as their benchmark, the efficacy data look “better than expected,” Mizuho Securities analysts said.
The company’s shares $ITCI climbed 24% to $80.62 on Tuesday morning.
Caplyta is also in a separate but identical Phase 3 test in MDD, with topline data expected late in the second quarter of 2024. Jefferies analysts said the next readout is now “derisked” with a more than 75% possibility of success. Whatever risk remains is “largely attributed to placebo” rather than lack of drug activity, they wrote.
“The positive Phase 3 results in MDD represent a significant step towards our goal of further establishing Caplyta as a first-choice treatment across mood disorders,” CEO Sharon Mates said in a statement.
Last year, Caplyta reached $462.2 million in net sales per an earnings release. In MDD, past precedents indicate that Caplyta could hit peak sales of at least $1 billion, the Jefferies analysts said. MDD affects around 21 million adults in the US each year, according to Intra-Cellular.