Ahmad Masri, MD, MS, discusses new acoramidis data from the ATTRibute-CM trial at AHA 2023.
New data from the ATTRibute-CM study presented at the American Heart Association Scientific Sessions 2023 is providing clinicians with even further insight into the effects of acoramidis in patients with transthyretin amyloidosis cardiomyopathy (ATTR-CM).
Adding to the growing understanding of the benefit-risk profile for acoramidis in ATTR-CM, results of the time-to-first event analysis for all-cause mortality and cardiovascular hospitalization indicated use of acoramidis was associated with a. 14.6% absolute risk reduction and a 36% relative risk reduction for the composite endpoint relative to placebo.
“The positive results of the ATTRibute-CM study demonstrate that acoramidis improved clinical outcomes for ATTR-CM patients, even in the contemporary care setting. The early and sustained benefit on survival and cardiovascular-related hospitalization is remarkable and builds evidence towards the therapeutic hypothesis that near-complete TTR stabilization may improve clinical outcomes for ATTR-CM patients,” said Daniel Judge, MD, professor of medicine and cardiology at the Medical University of South Carolina, and co-chair of the ATTRibute-CM Steering Committee.
With topline results of the trial announced in July 2023 and presented at the European Society of Cardiology 2023 Congress in August, excitement around the potential of the next-generation, oral, near-complete stabilizer of transthyretin from BridgeBio has continued to grow with each release of data. At HFSA 2023, long-term extension data from a phase 2 study provided data on the effects out to 55 months among a cohort of 25 patients from the initial trial.
At AHA 2023, investigators offer insight into a survival analysis of data from the trial, with an interest in examining the effect of acoramidis on a composite endpoint of all-cause mortality and cardiovascular hospitalization. For the purpose of analysis, investigators planned to use a Kaplan-Meier time-to-first event approach.
Results of the analysis suggested such an event occurred among 35.9% of the acoramidis cohort and 50.5% of the placebo cohort, which corresponds to absolute and relative risk reductions of 13.6% and 36%, respectively. Investigators pointed out further analysis using the 2-component Finkelstein and Schoenfeld test indicated a Win Ratio of 1.5 (95% Confidence Interval, 1.1 to 2.0; P=.0182) in favor of acoramidis.
In a release, BridgeBio pointed out their intent to submit an NDA for acoramidis to the US Food and Drug Administration before the end of 2023 and acoramidis is estimated to have intellectual property protection out to at least 2039.
For more on the results of this study and how it complements other data from the clinical program for acoramidis, check out our interview with study investigator Ahmad Masri, MD, MS, director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University, from AHA 2023.
Relevant disclosures for Masri include Cytokinetics, Bristol Myers Squibb, Eidos, Pfizer, Ionis, Lexicon, AstraZeneca, Tenaya, and others.