Mon, May 18, 8:47 AMFurther analysis of Phase 2 data show additional benefits of treatment with Intra-Cellular's ITI-007 in schizophrenia patients
- At the American Psychiatric Association meeting in Toronto, Intra-Cellular Therapies (NASDAQ:ITCI) presented additional data from a 335-subject Phase 2 clinical trial evaluating its lead product candidate, ITI-007, in patients with schizophrenia.
- The study met its primary efficacy endpoint of a statistically significant improvement in psychosis as measured by the change from baseline at day 28 in PANSS total score versus placebo.
- Patients in the intent-to-treat population who received once-daily 60 mg ITI-007 showed improved negative symptoms as did a subgroup of those with prominent negative symptoms. The effects were not observed in patients treated with risperidone (branded version: Janssen Pharmaceuticals' (NYSE:JNJ) Risperdol). Also, a subgroup of schizophrenia patients who had co-morbid depression that were treated with ITI-007 showed a statistically significant anti-psychotic effect not observed in the risperidone cohort.
- Treatment with ITI-007 demonstrated a favorable tolerability profile with little or no weight gain, favorable effect on metabolic measures and a reduced risk of akathisia (feeling of restlessness) and hyperprolactinemia (elevated prolactin in the blood which may cause breast enlargement in men).
- ITI-007 is currently in Phase 3 development.
- ITCI is up 5% premarket on light volume.
Thu, May 7, 12:09 PM
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Intra-Cellular Therapies, Inc. is a biopharmaceutical company. The Company is engaged in discovery and clinical development ofsmall molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders.
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