ITI-007 Phase 3 Results

Today Intra-Cellular released results from the second phase 3 clinical trial for Schizophrenia called ITI-301. The press release is here Phase 3 ITI-301. The results below show that there is some effect that drug ITI-007 has for Schizophrenia patients using the PANSS clinical endpoint to measure efficacy versus placebo. The results are as follows.

• 60mg -14.5    p = .022
• 40mg -12.9    p = .164
• Placebo -10.3

An active comparator such as Risperidone was not used in this clinical trial.
Regarding negative symptoms of Schizophrenia the following quote from the CEO in the press release. "Furthermore, both doses of ITI-007 improved the PANSS Negative Symptom subscale score more than placebo in the ITT population, but the improvement did not reach statistical significance in this 4 week study. These and additional data will be presented at upcoming scientific meetings".
The second phase 3 is currently running with an active comparator Risperidone called study ITI-302. Those results should give a better indication of the efficacy of ITI-007 for Schizophrenia. Thank you for reading.