Oct 8 (Reuters) – Italy’s Newron Pharmaceuticals said on Thursday the FDA had outlined safety concerns behind a clinical hold at US sites in a late-stage trial of its experimental schizophrenia drug, citing four deaths and irregular heart rhythms.
Shares of the Switzerland-listed company were down 8.5% in afternoon trading following the news.
Here are some details:
• The company said the FDA’s concerns were related to a known risk of irregular heart rhythms in patients enrolled in the trial
• The agency noted four deaths among patients who received evenamide across all studies, compared with one death among those given a placebo, as a potential safety signal
• 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 the 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 data from its studies, including more than 10,000 heart recordings from about 700 patients treated with evenamide
• It is assessing additional heart screening and monitoring measures as part of its response to the clinical hold
• 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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