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- Thinly traded Intra-Cellular Therapies (NASDAQ:ITCI) is up 32% premarket on increased volume in response to its announcement of positive results for its lead product candidate, ITI-007, in a Phase 3 clinical trial in 450 patients with schizophrenia. A once-daily dose of 60 mg met the primary endpoint and demonstrated statistically significant antipsychotic efficacy versus placebo.
- Study participants were randomized 1:1:1 to receive either ITI-007 60 mg or 40 mg or placebo once daily for four weeks. Patients were diagnosed with schizophrenia (DSM-5 criteria) and were required to have an acute exacerbation of psychotic symptoms. The primary efficacy endpoint was the change from baseline at week 4 in PANSS total score (symptom severity) versus placebo. Participants had a mean PANSS score of 89.8 at baseline (very ill). A key secondary endpoint was CGI-S, also a measure of symptom severity.
- The 60 mg cohort showed a statistically significant improvement in PANSS score versus placebo (p=0.022), but the 40 mg cohort did not (p=0.164). Both doses demonstrated statistically significant improvement over placebo on the CGI-S (p=0.003 and p=0.025, respectively), although the 40 mg could not be formally compared to placebo since it did not achieve the primary endpoint. The 60 mg group also showed a statistically significant improvement in social functioning as measured by the Personal and Social Performance Scale (PSP).
- ITI-007 was well tolerated and showed a safety profile similar to placebo. Notable was the lack of difference in weight gain compared to placebo, a typical consequence of taking antipsychotic medications.
- The company intends to present the results at a future medical conference.
- Management will host a conference call this morning at 8:30 am ET to discuss the data.
Feb. 18, 2015, 12:51 PM
Intra-Cellular Therapies, Inc. is a biopharmaceutical company, which focuses on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within... More
Industry: Drug Manufacturers - Major
Country: United States
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