Intra-Cellular Therapies’ surging antipsychotic Caplyta has scored again with remarkable trial results, fueling its bid for a third and potentially most lucrative indication—major depressive disorder (MDD).
In U.S. patients with MDD, a 42 mg daily dose of Caplyta (lumateperone) as an adjunctive therapy provided a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) at week 6 compared to placebo.
The 480-patient phase 3 study, coded Study 502, has therefore achieved its primary endpoint.
The study also hit its secondary objectives, including a statistically significant change from baseline to Week 6 on the Clinical Global Impression Scale for Severity of Illness (CGI-S) scoring system.
The results were strikingly similar to those that Intra-Cellular released two months ago for Study 501, which was conducted worldwide and included 485 patients. That trial showed a 4.9-point MADRS reduction versus placebo.
“We’re really pleased with the results of Study 502 and the consistency that we’ve seen,” Intra-Cellular CEO Sharon Mates, Ph.D., said in a conference call. “It really does lead us to conclude that lumateperone may be the drug of choice for the treatment of mood disorders.”
With the news, Intra-Cellular’s share price jumped by 11% by late morning.
The New York City-based company said it will apply for approval of lumateperone in MDD in the second half of this year. In April, when Study 501 readout, analysts from Leerink Partners said that the indication held blockbuster potential, projecting it would bring an additional $1 billion in peak sales by 2033, “which we think is conservative and certainly has the potential to be higher.”
On Tuesday, Mizuho Securities analyst Graig Suvannavejh, Ph.D., wrote in a note to clients that the results “came in better than our expectations” and “incredibly similar” to the data from Study 501. Muzuho had previously expected the MADRS improvement from Caplyta to fall in the 2- to 3-point range.
The trial results could give Intra-Cellular a leg-up in its competition with AbbVie’s antipsychotic powerhouse Vraylar, which was approved as an adjunctive treatment for MDD 18 months ago on top of its approvals for schizophrenia and bipolar disorder.
Two different dosages of Vraylar have produced MADRS improvements of 2.4 points and 2.9 points in trials, though Intra-Cellar’s chief medical officer Suresh Durgam reminded during the conference call of the unreliability of cross-trial comparisons.
Last year, while Vraylar’s sales were up 35% to $2.7 billion, Intra-Cellular reported sales of $462 million for Caplyta, which was approved by the FDA for schizophrenia in 2019 and bipolar disorder in 2021. The company has projected 2024 sales to fall between $645 and $675 million without any contribution from MDD.
Mates added that the company will provide more information in its next earnings call about its plan to beef up its sales staff in anticipation of an approval in MDD in the first half of 2025. She added that Intra-Cellular is in strong financial position, with $1 billion on its balance sheet and no debt.