BridgeBio Presents P-III Study (ATTRibute-CM) Results of Acoramidis for Transthyretin Amyloid Cardiomyopathy at ESC 2023
Shots:
- The P-III study evaluating acoramidis vs PBO showed improvement in primary outcome of interest with a Win Ratio of 1.8, survival rate (81% vs 74%) with absolute & relative risk reduction of 6.4% & 25%
- Rate of tafamidis use ~50% greater among PBO arm, 14.9% vs 21.3% CV-related mortality rate for a relative risk reduction of 30%, relative risk reduction of 50% on the frequency of CVH, significant treatment effect at 30mos. on change from baseline in NT-proBNP (45% vs 9%), KCCQ & 6MWD (40% vs 22%)
- Serum TTR was consistently elevated throughout the study; 42% increase in serum TTR levels over PBO + tafamidis in a comparative exploratory post hoc analysis. The result was consistent across variant, wild-type ATTR-CM & NYHA Class I, II & III patients. The company plans to file an NDA with the US FDA at the end of 2023
Ref: Globe Newswire | Image: BridgeBio
Related News:- BridgeBio Pharma Initiates P-III Study (CALIBRATE) of Encaleret for Autosomal Dominant Hypocalcemia Type 1
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
