BridgeBio Pharma Announces 12 Month Results from Phase 3 ATTRibute-CM Study

Dec 27, 2021 By MarketDepth

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BridgeBio Pharma, Inc. (NASDAQ: BBIO) has reported results from Month 12 of ATTRibute-CM.  ATTRibute-CM is a global phase 3 study that investigates acoramidis for treatment of sympromatic transthyretin amyloid cardiomyopathy.  The study displayed decline in both arms of ATTRibute-CM, similar to expected functional decline in healthy elderly adults.  “This result is disappointing and baffling. I am, along with many others, searching for answers regarding the 6MWD,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio. “The results do not appear to be due to a baseline imbalance. The hypotheses we are currently evaluating include context bias, training bias, and an evolution in diagnosis and standard of care. The drug does appear to be pharmacologically active and well-tolerated, and we observed improvement on quality of life with promising trends on adverse events leading to death. The drug seems to be doing what we are asking of it. If we observe enough clinical outcome events at Month 30, I am still hopeful that we will demonstrate the benefit of acoramidis treatment.”

“Although these results were not what we hoped, the most important moment in this trial will be the Part B readout at 30 months, where we will see the effects of acoramidis on all-cause mortality and cardiovascular hospitalizations. From what I’ve seen so far, I remain enthusiastic about getting to that endpoint.”

Daniel Judge, M.D., professor in the Division of Cardiology at the Medical University of South Carolina, and co-chair of the ATTRibute-CM Steering Committee