STAT+: Bellerophon Therapeutics trial fails despite innovative digital endpoint
In an important reminder that plugging digital tools into a clinical trial will not magically solve problems, Bellerophon Therapeutics announced Monday it would abandon a study of its treatment for pulmonary fibrosis after patients in a Phase 3 trial using a digital endpoint showed no improvement.
Bellerophon’s study, which the New Jersey-based company boasted was the first pivotal trial to use a Food and Drug Administration-endorsed endpoint using wearable data, was closely watched by larger biotech and pharma companies keen to incorporate technology into their clinical trials. Its INOpulse treatment — inhaled nitric oxide delivered through a cannula — was poised to be the first drug approved using a digital biomarker.
But things didn’t go as planned, and the company, whose market value was hovering just above $70 million after the close on Friday, will abandon the study following the topline results.
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