Experimental Schizophrenia Drug Shows Promise in Phase II

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A Phase II trial of Intra-Cellular's ITI-007 shows improvement in negative symptoms of schizophrenia without side effects seen in other antipsychotics.

A schizophrenia drug under development could benefit patients who are at risk of developing conditions including diabetes and cardiovascular disease, as well as weight gain, which are associated with some second-generation antipsychotics.

Additional analyses on Phase II data on ITI-007, a serotonin 5-HT2A receptor antagonist from Intra-Cellular Therapies, Inc., were presented at the recent American Psychiatric Association Annual Meeting in Toronto. The Phase II study, ITI-007-005, was a double-blind, placebo- and active-controlled trial enrolling 335 patients with an episode of schizophrenia.

Patients were randomized to receive one of four treatments: 60 mg ITI-007, 120 mg ITI-007, 4 mg risperidone (active control) or placebo.

The study reached its primary endpoint of statistically significant improvement in psychosis from change at baseline to day 28 based on the Positive and Negative Syndrome Scale (PANSS).  But patients in an intent-to-treat population who received 60 mg/day of ITI-007 showed improvement in negative symptoms, as well as another cohort who also had more pronounced negative symptoms.

Kimberly Vanover, PhD, Intra-Cellular’s vice president of clinical development, said at the meeting that these beneficial effects were not seen in the risperidone group. She added that a subgroup of schizophrenia patients with comorbid depression who took ITI-007 showed a significant anti-psychotic effect, which was not seen in the risperidone group either.

In another boon to ITI-007, patients treated with the drug showed little or no weight gain, and reduced risk of akathisia, or restless feeling, and hyperprolactinemia, a condition where high levels of prolactin in the blood may cause enlarged breasts in men. The risperidone group was associated with a modest weight gain of two kilograms, Vanover reported.

In the trial, patients received medication for 28 days and then received standard of care (SOC) for an additional five days. For patients taking either dose of ITI-007, their insulin, glucose and triglyceride levels continued to be low, but rose when they changed to SOC. In contrast, those levels were elevated in the risperidone cohort throughout the 28-day treatment period.

“Existing data provide evidence for the positioning of ITI-007 as a potential single stand-alone therapy for the treatment of multiple symptoms associated with schizophrenia including positive symptoms and negative symptoms and symptoms of impaired social function,”  Intra-Cellular CEO Sharon Mates, PhD, said in a statement.  

ITI-007 is currently in Phase III for schizophrenia.

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