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Stock Watch: Bridgebio’s Endpoint A Bridge Too Far

Switch From Surrogate To Clinical Endpoint Between Phase II and III Had Big Risks

 
• By Andy Smith

The news desert over the holidays meant that any Phase III clinical study announcement would be closely examined. Unfortunately, BridgeBio’s shock Phase III failure was made worse by elusive explanations.

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

The announcement of the results of the 12-month Part A component of BridgeBio Pharma, Inc.’s ATTRibute-CM study of acoramidis (formerly AG10), in 632 symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) patients, was supposed to provide a mandate for regulatory submissions. This was because the primary endpoint in the Phase III ATTRibute-CM study was a hard clinical measure – the six-minute walk distance (6MWD). This contrasted with the trial on which Biogen, Inc., gained a much contested and mostly un-reimbursed accelerated approval on the basis of a surrogate marker of disease.

The mean observed decline in 6MWD after 12 months was just over 9 meters for patients treated with acoramidis. This...

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