Tuesday turned out to be a nightmare for shareholders of Intra-Cellular Therapies Inc (NASDAQ:ITCI) after the company disclosed that its lead drug candidate ITI-007, an oral, first-in-class investigational medicine for the treatment of schizophrenia, had a similar rate of effectiveness to placebo in a Phase 3 schizophrenia trial.
Intra-Cellular shares reacted to the news, crashing 63% to $15.67.
“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.”
In this study, consistent with our previous schizophrenia studies, ITI-007 was well-tolerated with a safety profile similar to placebo. There were no clinically significant differences with ITI-007 from placebo in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, and lipids. As expected, risperidone demonstrated a statistically significant increase in weight gain, glucose, cholesterol, triglycerides and prolactin compared to placebo. These increases have a negative impact on patients. In contrast, ITI-007 was statistically significantly better than risperidone on all of these tolerability parameters. There were no significant increases observed with ITI-007 versus placebo on any of these parameters. There continues to be a need for safer and more tolerable medications for patients with schizophrenia, which are not associated with the motoric and cardio-metabolic side effects of many existing treatments, thereby potentially improving compliance and reducing relapse and hospitalizations. We believe ITI-007 has the potential to address this need.
“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. (Original Source)
On the ratings front, ITCI stock has been the subject of a number of recent research reports. In a report released today, JMP analyst Jason Butler downgraded ITCI to Hold. Separately, Suntrust Robinson Humphrey’s Edward Nash also downgraded the stock to Hold today.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Butler and Edward Nash have a total average return of 21.8% and 10.6% respectively. Butler has a success rate of 56% and is ranked #210 out of 4181 analysts, while Nash has a success rate of 47% and is ranked #735.
Overall, 2 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $29.00 which is 88.2% above where the stock opened today.
Intra-Cellular Therapies, Inc. is a biopharmaceutical company, which focuses on the discovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. Its lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. The company also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer’s disease, and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer’s disease.