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Aug 16, 2023

Bellerophon trial fails despite innovative digital endpoint

By Mario Aguilar June 5, 2023 In an important reminder that plugging digital

By Mario Aguilar June 5, 2023

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.

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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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Health Tech Correspondent

Mario Aguilar covers how technology is transforming health care.

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