Results, Setbacks

The 2nd PhIII schizophrenia study for Intra-Cellular drug is a disaster, shares shredded

A year after turning up some mixed schizophrenia data from their first late-stage study of their lead drug for schizophrenia, Intra-Cellular Therapeutics today said that the second late-stage trial was a near complete flop.

As in many similar studies, Intra-Cellular $ITCI says their psychiatric drug was done in by a high placebo response. And like many others, it is vowing to remain committed to the development program.

Investors had other ideas on that score. The New York-based biotech’s stock went into a meltdown once trading resumed, plunging 68% and erasing the lion’s share of its $1.8 billion market cap.

The first time out in Phase III, Intra-Cellular investigators said that the high dose proved more effective than a placebo in improving symptoms of schizophrenia. This time, though, neither dose of the 5-HT2A receptor antagonist did better. But the control drug risperidone did do better than the placebo, making it all the more difficult for company execs to explain away the flop.

Intra-Cellular’s drug actually did just a tad worse than placebo, and significantly worse than the risperidone control arm. “ITI-007 60 mg and 20 mg demonstrated a change from baseline on the PANSS total score of -14.6 points and -15.0 points respectively versus a -15.1 point change in placebo,” the company reported. “Risperidone, the active control, demonstrated a change from baseline on the PANSS total score of -20.5 points.”

Researchers fingered a few key trial sites for the unusually high placebo response.

The biotech swiftly tried to shift focus to an improved safety profile, adding that they have the money in hand needed to continue work on the drug. And they added that they still believe that the full set of data from a mid-stage study and the two Phase III trials proved that the drug is effective.

“Based on the strength of the clinical data generated in this program to date, including two positive studies, supportive evidence from Study ‘302 and a consistent, well-tolerated and placebo-like safety profile across all studies, we continue to believe ITI-007 will be an important treatment for patients suffering from schizophrenia. We remain committed to the development of ITI-007 for the treatment of schizophrenia, bipolar depression, agitation associated with dementia, including Alzheimer’s disease and other neuropsychiatric indications,” said Dr. Sharon Mates, Chairman and CEO of ITCI.


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