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First Clinical Safety Study Starts For Newron's Evenamide

Phase III Expected To Start In 2021 For The Potential Add-On Schizophrenia Therapy

 
• By John Davis

Following safety issues raised by the US FDA, no toxicity concerns have emerged in preclinical studies of Newron’s candidate schizophrenia therapy, evenamide, and a clinical safety study has started to evaluate its CNS effects.      

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• Source: Shutterstock

Italy’s Newron Pharmaceuticals SpA has initiated an explanatory clinical study of its potential add-on schizophrenia therapy, evenamide, to address potential safety issues raised by regulators in 2019. If successful, a Phase III clinical trial in chronic schizophrenia is expected to start in the second quarter of 2021.

The Milan-based company is evaluating options for partnering or co-developing evenamide, a voltage-gated sodium channel blocker and glutamate modulator, and...

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