NEW YORK— Biopharmaceutical company Intra-Cellular Therapies Inc. (ITI), touting its lead drug candidate ITI-007 as “a new type of antipsychotic,” recently reported positive topline results from the company's randomized, placebo- and active-controlled Phase 2 clinical trial of the compound in patients with acutely exacerbated schizophrenia.
In this study conducted by ITI, a company focused on the development of therapeutics for central nervous system disorders, ITI-007 met the trial's pre-specified primary endpoint, which was 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.
Many patients with schizophrenia have deficits in social function, such as the ability to recognize, understand, process and use external cues to solve problems, maintain work performance and conduct interpersonal relationships, ITI notes, and deficits in social function often remain after positive symptoms, such as hallucinations and delusions, have resolved in such patients.
“In the Phase 2 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 company reported in the news release about the study result. “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 events.”
“ITI-007 represents a new type of antipsychotic, where multiple behavioral actions are present and are dissociable by drug dose,” according to Dr. Carol A. Tamminga, chairman of the Psychiatry Department and chief of translational neuroscience research in schizophrenia at the University of Texas Southwestern School of Medicine, as well as chairman of ITI’s medical advisory board. “The robust antipsychotic efficacy of ITI-007 against a wide range of symptoms, augmented by its clean side effect profile demonstrated in this trial, suggests that ITI-007 may have broad utility in treating the multiple symptoms associated with schizophrenia in its acute and chronic phases with a single, stand-alone drug therapy.”
Expressing extreme pleasure over the outcomes of this clinical trial, Dr. Sharon Mates, president and CEO of ITI, added, “Not only was the primary objective of demonstrating antipsychotic efficacy achieved, but the study also revealed differentiating features of ITI-007, including improvements in a class of symptoms which may signal improved social function. We believe that this broad activity may indeed be related to ITI-007's mechanism of action, interacting broadly with the serotonin, dopamine and glutamate systems.”
