Intra-Cellular swings up on latest go-ahead from FDA
- After protracted uncertainty and discussions with the Food and Drug Administration, Intra-Cellular Therapies, Inc. says it is ready to move forward with a long-term safety study of its lead compound.
- The biotech now expects to submit a New Drug Application for its neuropsychiatric disease drug lumateperone (also known as ITI-007) in mid-2018.
- According to Intra-Cellular, the FDA judged data presented by the company adequately proved that toxicity seen in animals was due to different metabolic pathways than those in humans and therefore does not apply to humans.
Two years ago, Intra-Cellular shares soared when the company posted positive data for its schizophrenia treatment, ITI-007 (now known as lumateperone). The data showed the drug worked in high doses without increasing weight gain — a common side effect of psychiatric drugs. At the time, analysts estimated peak sales of $2 billion for the drug.
But optimism shifted to negativity a year later when Intra-Cellular disclosed neither dose of the drug was able to beat placebo in a late-stage study. The company attributed the bad results in Study '302 to an unusually high placebo response. But investors weren’t buying it: the active control arm with patients on Risperdal (risperidone) outperformed ITI-007 and placebo.
Even still, the FDA said there was enough evidence to move forward with testing and a filing.
Further complicating matters, the FDA asked for additional data in May regarding nonclinical toxicology studies performed on animals. Preclinical testing had shown some nasty toxicity issues in animals. The company, though, says this was due to unique metabolic pathways in animals and shouldn’t be a problem in humans. So far, it hasn’t been.
Intra-Cellular's current safety study will monitor patients for metabolites that could indicate the same toxicity that was previously seen in animals.
Once again, the biotech’s stock has taken a wild swing, jumping 30% on the news to reach $14.70 in morning trading Wednesday
Even if lumateperone can make it to market, the schizophrenia field is already pretty crowded. There are currently a number of low-cost generics, as well as several long-acting injectables that have improved compliance for this tough-to-treat patient population.
- Intra-Cellular Press release
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