Intra-Cellular Therapies announced Wednesday that it intends to submit a filing seeking FDA approval of the experimental schizophrenia drug lumateperone by the middle of next year. Shares in the drugmaker surged as much as 33 percent on the news.
The company unveiled its plans after the FDA completed a review of the drugmaker's responses to requests made earlier this year for additional information regarding certain findings in non-clinical toxicology studies. According to Intra-Cellular, the regulator agrees that "adequate data" has been presented "to support its position that the metabolic pathway in the animal species is distinctive from humans, which indicates that the toxicity observed in the animal species is not relevant to humans." CEO Sharon Mates remarked "we are very pleased with the outcome of our discussions with the FDA and look forward to progressing our schizophrenia programme."
Intra-Cellular also asked the agency to provide guidance concerning the acceptability of two previously conducted Phase III studies. According to the company, the FDA concluded that the results of the ITI-007-302 trial would not prevent a submission of lumateperone for FDA approval even though the study missed its main goals. Meanwhile, the drugmaker stated that efficacy was confirmed by the findings of the ITI-007-301 study.
Intra-Cellular explained that it is proceeding with a long-term safety study of lumateperone in patients with schizophrenia. Additionally, the company plans to include additional monitoring for metabolites identified in animal species, but not humans, to date, as well as monitor toxicity in non-clinical studies.
Lumateperone is also in Phase III development for the treatment of bipolar depression and agitation associated with dementia, including Alzheimer's disease.
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