Intra-Cellular Therapies Announces Update on ITI-007-201 Clinical Trial for Treatment of Agitation in Patients with Probable Alzheimer's Disease
“We are disappointed for patients suffering from Alzheimer's disease that the interim analysis did not detect a signal that would warrant continuation of this study. Effective clinical study design is a challenge, especially for a therapeutic indication for which there are no approved treatments," said Dr.
About Study 201
Study 201 was a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with a clinical diagnosis of probable Alzheimer's disease and clinically significant symptoms of agitation. In this trial, patients were randomized to receive 9 mg ITI-007 or placebo in a 1:1 ratio orally once daily for four weeks. The primary efficacy measure utilized the Cohen-Mansfield Agitation Inventory — Community version (CMAI-C). Other efficacy measures included a Clinical Global Impression scale for Severity (CGI-S) of illness. Safety and tolerability were also assessed in the trial.
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Lumateperone is under review by the
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our clinical and non-clinical development plans; the progress, timing and results of our clinical trials; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of lumateperone; our expectation that the results of this interim analysis and the decision to discontinue Study 201 will not impact any of our other ongoing development programs; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: whether the NDA for lumateperone for the treatment of schizophrenia will be accepted and approved by the FDA; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
Vice President, Corporate Communications and Investor Relations
Corporate Media Relations, W2Owcg
Source: Intra-Cellular Therapies Inc.