Home Health Care Intra-Cellular Therapies hits one, misses another in Phase III bipolar disorder program

Intra-Cellular Therapies hits one, misses another in Phase III bipolar disorder program


Shares of a New York-based drugmaker sank Monday following the announcement of data from two Phase III studies of an investigational drug for bipolar depression.

Intra-Cellular Therapies said that while one study of the drug lumateperone, Study 404, was positive and showed a statistically significant improvement compared with placebo, the other, Study 401, failed to show superiority to placebo.

Shares of the company fell 23 percent on the Nasdaq when markets opened Monday, from $13.46 to $10.30, and were still down 22 percent in the afternoon.

Study 404, wherein 381 patients were randomized to receive either lumateperone at 42mg or placebo, the drug showed met the primary endpoint of showing a statistically significant improvement at week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. But in Study 401, which randomized 554 patients to receive the drug at 42mg, 28mg or placebo, neither dose of the drug showed separation from placebo, and there was a high rate of patients responding to placebo itself. Both Study 404 and Study 401 – the latter of which took place only in the U.S. – showed a favorable safety profile and tolerability for the drug.

“We consider today’s positive results to be a significant milestone in our bipolar depression program,” said CEO Sharon Mates in a statement. “The distinct pharmacological profile of lumateperone and positive clinical results in schizophrenia and bipolar depression further support the potential for benefits in a broad range of neuropsychiatric conditions, including major depressive disorder.”

In a note to investors Monday, Cowen analyst Ritu Baral wrote that it is unclear why the placebo response rates differed so much between the two studies, given that the company had noted the mix of bipolar 1 and bipolar 2 disorder patients was similar. She also noted that a subanalysis of US sites in Study 404 also showed statistically significant efficacy. Baral pointed also to the company stating that placebo response rates in neuropsychiatric trials have been increasing over time due to improvements in standards of care, while Study 401’s 1:1:1 randomization – compared with the 1:1 randomization in Study 404 – may also have contributed to the high placebo response rate in the former.

Photo: SIphotography, Getty Images

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