Intra - Cellular Therapies - Phase 3 trial of ITI - 007 for Schizophrenia

Intra-Cellular Therapies, Inc. ITCI, +2.20% a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, announced today that the first patient has been enrolled in the ITI-007-301 Phase 3 trial, a randomized, double-blind, placebo-controlled trial designed to demonstrate the efficacy of ITI-007 for the treatment of schizophrenia. The Company anticipates top-line results from this trial could be available as early as the fourth quarter of 2015.


First generation antipsychotics: dopamine regulation

Second generation antipsychotics: dopamine + serotonin regulation

(Third) generation antipsychotics: dopamine + serotonin + glutamate regulation

I will reconsider antipsychotics when truly revolutionary mechanisms of action are developed. I can’t help the impression that drug companies are tinkering in the dark.

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I’m sure you’ve seen this research by Paul Greengard that shows, in terms of neurotransmitters, we won’t get better than a “third generation” drug.

Thanks @Wave. This looks promising.

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“In this study, ITI-007 met the trial’s pre-specified primary endpoint,
improving symptoms associated with schizophrenia as measured by a
statistically significant and clinically meaningful decrease in the
Positive and Negative Syndrome Scale (PANSS) total score. The trial also
met key secondary outcome measures related to efficacy on PANSS
subscales and safety.”

“In the Phase II trial, ITI-007 exhibited a differentiating response
profile across a broad range of symptoms that we believe is consistent
with improvements in these social functioning deficits. The study also
showed that ITI-007 was well-tolerated at the tested doses. ITI-007
demonstrated a favorable safety profile in the study without
characteristic antipsychotic drug side effects or any serious adverse

“In the Phase 2 trial, ITI-007 was well-tolerated. The most frequent
adverse event was sedation, as described above. There were no serious
adverse events related to ITI-007. There were no clinically meaningful
changes in safety measures with ITI-007. Notably, ITI-007 demonstrated a
favorable metabolic profile with no increase of blood levels of
glucose, insulin, cholesterol or triglycerides over a four-week
treatment period. Moreover, in contrast to risperidone, 60 mg of ITI-007
was effective with no difference from placebo on weight change
parameters, prolactin levels, extrapyramidal symptoms (EPS) or
akathisia. ITI-007 was not associated with EPS as measured by the
Simpson-Angus Scale, Barnes Akathisia Rating Scale, or Abnormal
Involuntary Movement Scale. There was no increase in suicidal ideation
or behavior with ITI-007.”

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This site organizes the pros over risperidone well in the phase 2 trials

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I doubled my money on ITCI. But, it should outperform the market again. Not a bad investment and last I’ve head they are comparing it to Risperdal in terms of efficacy. Something to look forward to! see


Now this is what interests me the most about the drug

Plus, it is considered the first of the 3rd generation of atypical antipsychotics. It works on the dopaminergic, serotonergic, and glutamanergic systems at the same time on the DARPP-32 “master molecule”.

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I’m quite intrigued about iti-007. I wonder if it’s gonna be good?

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