ITI-007 is an investigational drug being developed for schizophrenia and other neuropsychiatric/neurodegenerative diseases. ITI-007 has a unique pharmacological profile, combining potent 5-HT2a receptor antagonism with cell-type-specific dopamine and glutamate receptor modulation, plus serotonin reuptake inhibition. At dopamine-D2 receptors, ITI-007 acts as a post-synaptic antagonist and pre-synaptic partial agonist. Additionally, ITI-007 stimulates phosphorylation of glutamatergic NMDA-NR2B receptors, downstream of dopamine-D1 receptor intracellular signaling. Based on a large, placebo and risperidone controlled, Phase-II trial, ITI-007 60 mg was shown to be effective in reducing symptoms in patients with acutely exacerbated schizophrenia. The antipsychotic efficacy of ITI-007 60 mg in this patient population was confirmed in a recently completed Phase III study. ITI-007 was associated with minimal safety risk compared to risperidone (Phase II study) or placebo (both studies) for neuromotor disturbances, prolactin changes, weight gain and metabolic abnormalities. A second 6-week, placebo and risperidone-controlled Phase-III trial in acutely exacerbated schizophrenia is ongoing.
Intra-Cellular (NASDAQ: ITCI) said today that its prospective schizophrenia drug ITI-007 succeeded in the first of two Phase 3 trials. The higher of two doses of the drug (60 mg) met the primary and all key secondary goals of the study (the lower, 40 mg dose, did not). Specifically, after four weeks of treatment, the 60 mg dose of ITI-007 led to a statistically significant improvement in patients’ scores on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale for Severity of Illness—two common ratings scales used to judge the effectiveness of treatments for schizophrenia and other mental health disorders—compared to a placebo.
@Brea99 reviewed rexulti as they were on it, and I think they had problems with anxiety. This has put me off it somewhat. But they seem to be doing well on Vraylar so far, which is similar to abilify / rexulti.
