The 2nd Phase III trial of ITI-007 missed its endpoints. This will greatly delay or end adoption of the medicine.
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced top-line results from the second Phase 3 clinical trial (Study ‘302) of ITI-007, an oral, first-in-class investigational medicine for the treatment of schizophrenia. In this trial, neither dose of ITI-007 separated from placebo on the primary endpoint, change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score, in the pre-defined patient population. The active control, risperidone, did separate from placebo. In this trial, ITI-007 was statistically significantly better than risperidone on key safety and tolerability parameters and exhibited a safety profile similar to placebo. This replicates the safety and tolerability findings of a previous study (our Phase 2 Study ‘005) in which the efficacy of ITI-007 60 mg and risperidone, the active control, were similar. We believe ITI-007 did not separate from placebo on the pre-specified primary endpoint in Study ‘302 in part due to 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. Drug development in psychiatry faces numerous challenges and approved antipsychotics have had negative results as part of their clinical development programs. We are committed and adequately resourced to continue the development of ITI-007 for the treatment of schizophrenia. We believe the ITI-007 late-stage clinical development program, including two large, well-controlled positive studies and supportive evidence from this Study ‘302, collectively provide evidence of the efficacy and safety of ITI-007 for the treatment of schizophrenia. Across all three of our efficacy trials, ITI-007 60 mg improved symptoms of schizophrenia with the same magnitude of change from baseline in the primary endpoint, the PANSS total score. We plan to request a meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatry Products to discuss the regulatory path for this first-in-class investigational agent.
Intra-Cellular tanks on Phase III schizophrenia trial failure
Intra-Cellular Therapies ($ITCI) shed about $1.2 billion in market cap on the top-line data on a Phase III trial for its ITI-007 to treat schizophrenia that missed the primary endpoint. The company worked to blame the miss on an unusually strong placebo response, but an active control arm with risperidone actually outperformed both the placebo and the treatment groups.
Last September, the company skyrocketed on mixed Phase III results from the first trial in which the high dose of ITI-007 met the primary endpoint of significantly improving schizophrenia symptoms compared with placebo but the low dose in the study did not. At that time, IntraCellular shot up more than 75%; now it’s dropped off again by roughly two-thirds.
The company remains undeterred and it expects to meet with the FDA to discuss a regulatory path for ITI-007, based on the argument that across three trials the high dose of 60 mg has consistently improved symptoms of schizophrenia with the same magnitude of change from baseline in the primary endpoint.
Drug development in psychiatry faces numerous challenges and approved antipsychotics have had negative results as part of their clinical development programs. We are committed and adequately resourced to continue the development of ITI-007 for the treatment of schizophrenia. We believe the ITI-007 late-stage clinical development program, including two large, well-controlled positive studies and supportive evidence from this Study ‘302, collectively provide evidence of the efficacy and safety of ITI-007 for the treatment of schizophrenia. Across all three of our efficacy trials, ITI-007 60 mg improved symptoms of schizophrenia with the same magnitude of change from baseline in the primary endpoint, the PANSS total score. We plan to request a meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatry Products to discuss the regulatory path for this first-in-class investigational agent.
So basically what they’re saying is, that the drug doesn’t work, but it’s still safe. So even though the drug doesn’t work better than placebo at controlling sz symptoms, at one time it did and because of that, they are gonna take it up with the advisory board and see if we can overlook this last trial. I had high hopes for this drug, but if it doesn’t work at controlling symptoms what good is it if it still gets released.
Hey guys new here but been tracking this drug for a while hoping to take it in the future. The trial was unsuccessful because of the unusually high response from people taking the placebo. The PANNS score of patients taking Iti 007 was basically the same in all the trials, -13.2, -14.5, and -15 meaning the drug was equally effective in all trials. As a comparison the PANNS score of risperidone was -13.4 in the first trial and -20 in the last trial. What changed was the response from taking placebo. The PANNS score in the first 2 trials was -7.4 and -10 and then in this final trial shot up to -15. Although I’m concerned Iti 007 didn’t pass the trial I’m still hopeful it hits the market and is a viable treatment option
if u read the the actual press release, it unambiguously says they still think iti 007 is useful for sz. They are gonna try to get fda approval, and they mention other psychiatric drugs have gotten negative results but been approved.
This is what happens when ur shootin in the dark, tryin to make medications. It’s a wonder to me how they aim to make any sz drug, i dunno how u can approach it while knowing next to nothing about the biology involved.
I think iti was just trying to create a drug that would have the same biological cascade as current meds. That seemed to be their patented innovative approach from what i read.
I still reeling from this. I’ll probably be on abilify for the rest of my life. Part of the reason I was putting up with abilify was I thought it was just temporary until iti-007 came out. How stupid was that?
Vraylar and Rexulti are still on their way to Europe, maybe you can try them out when they arrive? You seem to be doing well on Abilify, though. Aside from the blood sugar issue of course.
. I hope MIN-101 to be a better med than ITI-007.