BridgeBio Pharma (NASDAQ: BBIO), a leading biopharmaceutical company, announced significant outcomes from the ATTRibute-CM, their Phase 3 study of acoramidis, for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
Superior Efficacy of Acoramidis Shown in Clinical Trial
The trial recorded a highly statistically significant improvement in the primary endpoint with a Win Ratio of 1.8 (p<0.0001). A meaningful separation was observed across all measures of mortality, morbidity, function, and quality of life. An impressive 81% on-treatment survival rate was achieved as opposed to a 74% survival rate on placebo. Notably, the risk of cardiovascular-related hospitalization was reduced by a significant 50% (p<0.0001) with the acoramidis treatment.
Secondary Endpoints Demonstrate Consistent Treatment Benefit
Treatment benefits were also observed in secondary endpoints such as NT-proBNP, KCCQ, and 6-minute walk distance, all of which showed a highly significant and clinically meaningful improvement at 30 months (p<0.0001).
Comparative Analysis Supports Promising Outcomes of Acoramidis
Post hoc comparative analysis showed that acoramidis resulted in a 42% greater increase in serum TTR levels and a 92% improvement in median NT-proBNP relative to placebo + tafamidis.
Safety and NDA Filing
No safety signals of clinical concern were identified during the trial. Further enhancing the significance of these results, BridgeBio intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2023.
Acoramidis Paves the Way for Future Treatment
The ATTRibute-CM trial’s positive results offer new hope for patients with ATTR-CM. As per Dr. Daniel Judge, co-chair of the ATTRibute-CM Steering Committee, the results are truly remarkable. The robust findings confirm the potential of potent TTR stabilization to impact patients’ lives significantly. Acoramidis shows promise as a potent, orally-administered, small molecule stabilizer of transthyretin, positioning BridgeBio at the forefront of genetic diseases and cancers treatment research.
BridgeBio’s Continued Commitment to Research and Development
The filing of the NDA is part of the company’s commitment to develop medicines that target diseases at their source, reflecting BridgeBio’s overall portfolio strategy. Acoramidis has intellectual property protection until at least 2039, ensuring its long-term potential as a groundbreaking treatment option.
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