Novartis’s app trial goes Pear shaped


Pear Therapeutics' reputation as the poster child for digital health therapeutics took another hit yesterday after Novartis published results of a 112-patient clinical trial, showing no difference between Pear-004 and a sham app in managing schizophrenia symptoms. The disappointing results are not expected to stall the launch of a newer version of Pear-004, which is being rolled out now. But the data will almost certainly hit sentiment towards the updated app. The original version tested by Novartis was authorised for use last April under new FDA guidance that waived a number of regulatory requirements in the wake of the Covid-19 pandemic. Pear yesterday launched its defence of the app by questioning Novartis’s trial methodology. The study disappointment comes 15 months after Novartis served notice on parts of its wider collaboration with Pear. The Swiss group's Sandoz subsidiary handed back rights to commercialise the Reset and Reset-O digital prescription therapies for substance abuse in October 2019. With these therapeutics still in their infancy the Pear-004 trial failure and any other stumbles are likely to be seen as bellwethers for this fledgling field.

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