Intra-Cellular Shares Collapse Nearly 70%: Here’s What You Need To Know
Intra-Cellular Therapies (NASDAQ: ITCI), a biopharmaceutical company that focuses on the discovery and development of molecule drugs to address underserved medical needs in neuropsychiatric and neurological disorders, saw its stock collapse nearly 70 percent after Wednesday’s market close.
The company announced top-line results from the second Phase 3 clinical trial called Study ‘302 which explores the company’s investigational medicine called ITI-007 with patients suffering from schizophrenia.
The first Phase 3 trial was positive and completed last year and consisted of 450 patients. However, top-line results from the second Phase 3 trial involving 696 patients was not a success.
The 696 patients suffering from schizophrenia were given a dose of ITI-007 and the pre-specified primary efficacy measure was change from baseline versus a placebo. The company announced on Wednesday that its ITI-007 failed to meet its primary endpoint.
Intra-Cellular said that it saw an “unusually high placebo response at certain sites which disproportionately affected the trial results and contributed to the efficacy outcome of this study compared to our two previous positive efficacy studies.”
“It is not uncommon in the field of psychiatry for studies to be challenged by high placebo response and there has been great variability in the effects observed from one study to the next,” said Christoph Corell, M.D., Professor of Psychiatry at Hofstra Northwell School of Medicine. “Taken together, the ITI-007 schizophrenia program supports ITI-007 as a unique medication with an unprecedented safety and tolerability profile. Moreover, efficacy has been demonstrated in two large-scale schizophrenia studies to date. In one of these studies, ITI-007 and risperidone, the active control, had similar efficacy. In light of the results to date, I believe that ITI-007 represents a unique investigational medication which has the potential to advance the treatment of patients suffering from schizophrenia.”
“Based on the strength of the clinical data generated in this program to date, including two positive studies, supportive evidence from Study ‘302 and a consistent, well-tolerated and placebo-like safety profile across all studies, we continue to believe ITI-007 will be an important treatment for patients suffering from schizophrenia. We remain committed to the development of ITI-007 for the treatment of schizophrenia, bipolar depression, agitation associated with dementia, including Alzheimer’s disease and other neuropsychiatric indications,” said Dr. Sharon Mates, Chairman and CEO of ITCI.