Intra-Cellular says to move forward with lumateperone long-term safety study

Intra-Cellular Therapies (ITCI) announced that the U.S. 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.

Lumateperone (developmental code names ITI-007, ITI-722) is an investigational atypical antipsychotic which is currently under development by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb (BMY), for the treatment of schizophrenia. It is also being developed by Intra-Cellular Therapies for the treatment of bipolar disorder, depression, and sleep and behavioral disturbance in dementia, autism, and other neuropsychiatric disorders

Accordingly, the Company is moving forward with its long-term safety study of lumateperone and intends to submit a new drug application for the treatment of schizophrenia by mid-2018.

The Company previously announced that the FDA had raised questions relating to certain findings observed in nonclinical toxicology studies of lumateperone in an animal species and requested additional information to confirm that the nonclinical findings are not indicative of a safety risk associated with long term exposure in humans.

The data presented by the Company supports the position that there are significant species differences in the metabolism of lumateperone.

Based on the FDA’s agreement that the Company presented adequate data indicating that the toxicity seen in the animal species is not relevant to humans, the Company is proceeding with its long-term safety study of lumateperone in patients with #schizophrenia.

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.

With over 1,500 people exposed to date, lumateperone has been well-tolerated with a safety profile similar to placebo.

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