BridgeBio Pharma Inc shares surged 69% to $30.78 in late-morning trading on Monday after the commercial-stage biopharmaceutical company announced that Acoramidis, its drug development candidate for a rare heart disease, showed significant improvement in patients in a late-stage study.
Acoramidis is being developed to treat transthyretin amyloid cardiomyopathy, which happens when abnormal deposits of a protein called amyloid buildup in the heart, and can cause heart failure.
The drug is expected to compete with Alnylam Pharmaceuticals (NASDAQ:ALNY)' patisiran, which is under regulatory review for cardiomyopathy, and Pfizer's Vyndamax, or tafamidis, already approved in the US for the condition.
The trial results showed that Acoramidis was 1.8 times better than placebo when measured for preventing death, hospitalization and improvement in six minutes walking distance, while improving survival by 81% in the study patients compared to 74% on the placebo, and also reduced frequency of heart disease-related hospitalization by 50%, the company stated.
As well, BridgeBio provided additional data comparing it with Pfizer's drug, which indicated a 92% improvement with Acoramidis in a heart failure test, compared to patients on placebo and Pfizer's drug at 30 months.
Acoramidis has intellectual property protection out to at least 2039, and the company said it plans to submit the data to the US Food and Drug Administration (FDA) by the end of 2023 as part of its marketing application.
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