Intra-Cellular Therapies’ schizophrenia drug fails in phase 3 trial

It was the second late-stage study for ITI-007. In an earlier phase 3 study, the drug was tested against a placebo, and the higher of two doses succeeded.

In the study being reported currently, ITI-007 was compared to the standard-of-care schizophrenia drug risperidone (Risperdal).

The study had a primary endpoint of change from baseline on the Positive and Negative Syndrome Scale score.

The two ITI-007 doses, 60 mg and 20 mg, in the trial showed a change from baseline of minus 14.6 points and minus 15 points, compared with minus 15.1 points in placebo and 20.5 in risperidone.

Intra-Cellular said there was an unusually high placebo response at several sites which disproportionately affected the trial results.

The company noted that ITI-007 performed better than risperidone on key safety and tolerability parameters and had a safety profile similar to placebo.

Intra-Cellular Therapies chairman and CEO Sharon Mates said: "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.” 

Schizophrenia is a disabling and chronic mental illness affecting more than 1% of the global population.