Oct 8 (Reuters) – Italy’s Newron Pharmaceuticals said on Thursday the US FDA had identified four deaths among patients treated with its experimental schizophrenia drug in feedback following the agency’s earlier decision to place a clinical hold on the treatment’s trial in the US.
Shares of the Switzerland-listed company fell 5.7% in afternoon trading after the US Food and Drug Administration raised safety concerns, including the potential risk of irregular heart rhythms.
Here are some details:
• The agency noted four deaths among patients who received evenamide across all studies, compared with one death among those given a placebo
• The FDA characterized the four deaths as a potential safety signal because a fatal arrhythmic mechanism could not be definitively excluded, Newron said.
• The drug was tested in people with treatment-resistant schizophrenia, a serious mental illness that affects thinking, emotions and perception of reality
• The feedback comes after the FDA earlier this year placed a clinical hold on new patient enrollment in a late-stage trial of evenamide following a patient’s sudden death, although the event was unrelated to the treatment
• Newron said trial investigators considered three of the four deaths unrelated to evenamide. One was considered possibly related because two autopsies did not determine a cause of death
• The company said it has not identified a pattern of heart abnormalities or irregular rhythms in its preclinical and clinical safety data
• Newron is reviewing the FDA’s feedback and the broader safety data generated across the evenamide development program and it plans to submit a response
• Newron said the clinical hold remains in place and enrollment in the trial is continuing outside the US
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shreya Biswas)
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