NEW YORK, May 18, 2016 (GLOBE NEWSWIRE) – Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it presented posters related to ITI-007, the Company’s lead product candidate, at the 2016 Society of Biological Psychiatry (SOBP) Annual Meeting and the 2016 American Psychiatric Association (APA) Annual Meeting.
The poster presentations featured additional data from the Company’s previously reported two positive ITI-007 schizophrenia clinical studies.
SOBP poster #1036 entitled: “Unique Pharmacology of ITI-007 Confers Efficacy in the Treatment of Schizophrenia at Low Striatal D2 Receptor Occupancy Levels” was presented on May 14th.
APA poster #P6-146 entitled: “ITI-007 for the Treatment of Schizophrenia: Primary & Secondary Efficacy Endpoints and Subgroup Analyses from Two Positive Randomized, Double-Blind, Placebo-Controlled Trials,” was presented on May 16th.
Two positive ITI-007 clinical trials, the Company’s Phase 3 Study ‘301 and Phase 2 Study ‘005, in schizophrenia have been completed. In both trials, ITI-007 60 mg demonstrated antipsychotic efficacy as measured by change in the Positive and Negative Syndrome Scale (PANSS) total score versus placebo at study endpoint. ITI-007 required no dose titration, showed early onset and sustained efficacy. ITI-007 was well-tolerated with a placebo-like safety profile.
A pooled efficacy analysis from Studies ‘301 and ‘005 was presented for ITI-007 60 mg. The pooled analysis confirmed efficacy of ITI-007 in patients with schizophrenia. This dose of ITI-007 was statistically significantly superior to placebo as early as week 1, with continued superiority to placebo demonstrated through the last study endpoint on Day 28 (p=0.0002; ES: 0.359).
APA poster #P6-147 entitled: “ITI-007 for the Treatment of Schizophrenia: Safety & Tolerability Data to Date from Two Double-Blind, Randomized, Placebo-Controlled Clinical Trials,” was presented on May 16th.
In the Company’s Phase 3 Study ‘301 and Phase 2 Study ‘005, ITI-007 was well-tolerated with a placebo-like safety profile. The most frequent treatment-emergent adverse events occurring in both studies and considered at least possibly related to ITI-007 were predominantly mild sedation/somnolence. In addition, ITI-007 demonstrated a motoric and metabolic profile similar to placebo.
