Schizophrenia drug shows promise in phase II trials; phase III to commence soon

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A novel schizophrenia drug dubbed ITI-007, which is a serotonin 5-HT2A receptor antagonist, is showing promising signs, Kimberly Vanover, PhD, of Intra-Cellular Technologies in New York City, which is developing the medication revealed at American Psychiatric Association (APA) 168th Annual Meeting being held in Toronto, Canada.

Vanover revealed that ITI-007 was safe and well tolerated in a phase II trial and has had beneficial effects on the total symptom score over a 28-day treatment period that were comparable with those seen with risperidone (Risperdal).

ITI-007, at a dose of 60 mg, demonstrated a statistically significant improvement in psychosis on the trial’s pre-specified primary endpoint, which was a change from baseline on the PANSS total score, compared to placebo on Study day 28, Vanover revealed. “At 60 mg, ITI-007 demonstrated a differentiated efficacy response profile including improvements in negative symptoms, depression and prosocial behavior”, she said.

60 mg ITI-007 improved negative symptoms in both the overall intent-to-treat (ITT) population and in the pre-specified subgroup of patients with prominent negative symptoms at baseline. In a subgroup of schizophrenia patients who had co-morbid depression, ITI-007 60mg showed a rapid, robust and statistically significant anti-psychotic effect not observed with risperidone. Furthermore, ITI-007 60mg consistently and significantly improved depressive symptoms in this subgroup, the company revealed.

As far as safety and tolerability is concerned, ITI-007 demonstrated a favorable tolerability profile with little or no weight gain, a favorable effect on metabolic parameters, and a reduced risk for akathisia and hyperprolactinemia. The drug had little or no effect on weight gain analyses including placebo-adjusted mean weight gain by clinical site. In contrast, risperidone resulted in weight gain of approximately 2 kg after adjusting for placebo response.

ITI-007 demonstrated a low relative risk of akathisia, with rates of akathisia similar to placebo, in contrast to risperidone which showed a relative risk 3X that of placebo.

Patients treated with conventional or newer second generation antipsychotic drugs (SGAs) for schizophrenia have an increased risk of diabetes and other associated diseases including cardiovascular disease, resulting in a significant burden on our healthcare system. Altered metabolic parameters are known to increase disease risk following certain antipsychotic drug use. Prominent among these metabolic risk factors are elevations in plasma glucose, insulin and triglyceride levels. Existing data suggests that ITI-007 does not impact these metabolic parameters in patients with schizophrenia and may have a substantial potential benefit for this patient population.

“The additional analyses presented at APA continue to demonstrate ITI-007’s unique safety profile. We believe the finding that patients’ metabolic parameters and prolactin are low while on ITI-007, then worsen after being switched to standard of care antipsychotic therapy, speaks to the beneficial profile of ITI-007,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

“We believe these analyses continue to support the unique potential benefits of ITI-007 for patients, their families, and the healthcare system. 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.”