Xconomy: Intra-Cellular Shares Sink As Schizophrenia Drug Flunks Final Test
Summary
Shares of New York-based Intra-Cellular (NASDAQ: [[ticker;ITCI]]) cratered late Wednesday, falling more than 67 percent in after-hours trading after the company disclosed that its experimental schizophrenia drug ITI-007 had failed a Phase 3 trial.The high dose of ITI-007, meanwhile, produced a “similar magnitude in change” in each of the three trials, senior vice president of clinical development Kimberly Vanover said on a conference call with analysts Wednesday afternoon.CEO and chairman Sharon Mates repeatedly mentioned on the conference call that ITI-007’s safety profile was “similar to placebo.” It didn’t cause the weight gain or increases in a variety of cardiometabolic measures (like cholesterol or triglycerides) commonly associated with risperidone or other antipsychotic drugs—something Correll pointed to as well.In its statement, the company said that certain approved antipsychotics have had negative trial results, that the data it’s accumulated “collectively provide evidence of the safety and efficacy of ITI-007,” and that it intends to meet with the FDA to discuss the regulatory path forward for the drug.Fernandez noted that a “confusing dose response” makes it difficult to interpret how effective ITI-007 is, and that as a result the FDA will likely require more trials before approving the drug.