Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenanc...( Trial Concluded Early Due to Achieve...),Health

"Trial Concluded Early Due to Achievement of Statistical Significance Demonstrated at the Primary Endpoint"

NEW YORK, Jan. 13 /PRNewswire/ -- Intra-Cellular Therapies, Inc. today announced successful top-line efficacy results for ITI-007 from a Phase II trial in Insomnia characterized by difficulty in maintaining sleep, also known as sleep maintenance insomnia (SMI). These data demonstrate that ITI-007 is safe and well-tolerated and demonstrate efficacy in reducing sleep disturbances. ITI-007 is the Company's first-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatment of schizophrenia. A low dose formulation of ITI-007 (formerly referred to as ITI-722) whose actions are predominantly mediated by 5HT2A receptor antagonism is being developed for the treatment of SMI.

"The results that we have analyzed to date from this study are encouraging. Based on the robustness of the effects observed at the interim analysis, and after extensive consultation with outside sleep experts, we have decided to conclude this phase of the trial for ITI-007 ahead of time with only half of the planned enrollment," stated Sharon Mates, Chief Executive Officer of Intra-Cellular Therapies. "We are now moving forward with an analysis of all other outcome measures and look forward to the continued development of ITI-007 in patients who suffer from Primary or comorbid Insomnia. Furthermore, these data serve to demonstrate the potential of ITI-007 as a next generation antipsychotic and treatment for sleep disorders in various patient populations including depression, bipolar disorder, Alzheimer's disease, mild cognitive impairment and other neuropsychiatric and neurodegenerative disorders where there is clear unmet medical need."

SUMMARY OF PHASE II SMI RESULTS

ITI-007 is an orally available drug candidate being evaluated at low doses in patients with SMI. An i
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