Intra-Cellular Therapies: FDA 'agrees that the Company has presented adequate data to support its position' in nonclinical toxicology studies of lumateperone in an animal species; co intends to submit a NDA by mid-2018
Co announced that the FDA has informed the Company that the FDA (i) has completed its review of the Company's responses to requests from the FDA for additional information relating to certain findings observed in nonclinical toxicology studies of lumateperone in an animal species and (ii) agrees that the Company has presented adequate data 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.
- Accordingly, the Company is moving forward with its long-term safety study of lumateperone and intends to submit a NDA for the treatment of schizophrenia by mid-2018. Further, based on feedback from the FDA, the Company will incorporate additional monitoring in its long-term safety study for metabolites seen in animal species but not seen to date in humans, and also will continue to monitor for toxicities in its nonclinical studies.
To address long term safety and to observe the impact of switching from standard-of-care antipsychotic medications, the Company is conducting an open-label safety study in stable patients with schizophrenia switched to lumateperone (ITI-007 60 mg) from standard of care antipsychotic therapy.
- This study is being conducted in two parts.
- The first part has completed clinical conduct and included a 6-week treatment duration with lumateperone followed by a 2-week period where patients are switched back to standard-of-care.
- This study assesses both the impact of switching to lumateperone from standard-of-care antipsychotics as well as the impact of switching back to standard-of-care antipsychotics from lumateperone.
- Topline data from the first part of the study will be available shortly.
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