Acoramidis Shows Significant Decrease in Cardiovascular Mortality Through 42 Months in ATTRibute-CM Open Label Extension

Acoramidis and Cardiovascular Mortality

• Significant Reduction in CVM: Acoramidis has shown a 44% reduction in the hazard of cardiovascular mortality (CVM) over 42 months post-randomization, establishing a new benchmark for outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM).
• Composite Outcome Improvement: The treatment also resulted in a 46% hazard reduction in the risk of a composite outcome of CVM or first cardiovascular hospitalization (CVH) during the same period.

Disease Stabilization and Improvement

• Higher Rates of Stabilization: Compared to placebo, acoramidis demonstrated higher rates of disease stabilization or improvement, as indicated by changes in NT-proBNP levels and NAC Stage assessments.
• Rapid Benefits Observed: In the ATTRibute-CM study, acoramidis exhibited the fastest benefits recorded in any Phase 3 study for ATTR-CM, with significant improvements noted as early as 3 months.

Clinical Trial Results

• Event Reduction: At Month 30, there was a 42% reduction in composite events of all-cause mortality (ACM) and recurrent CVH compared to placebo, alongside a 50% reduction in the cumulative frequency of CVH events.
• NT-proBNP Improvement: By Month 30, approximately 50% of participants treated with acoramidis showed improved or stable NT-proBNP levels, compared to less than 20% in the placebo group.

Regulatory Approvals and Future Plans

• FDA and European Approvals: Acoramidis is marketed as Attruby in the U.S. and as BEYONTTRA in Europe, Japan, and the UK, with all approvals highlighting its near-complete stabilization of transthyretin (TTR).
• Ongoing Research: Additional data on the benefits of Attruby for ATTR-CM patients are anticipated for future medical meetings, indicating ongoing commitment to research and development in this area.

Safety Information

• Adverse Reactions: Common adverse reactions reported include diarrhea (11.6% vs. 7.6% in placebo) and upper abdominal pain (5.5% vs. 1.4% in placebo), with most being mild and resolving without discontinuation of the drug. Discontinuation rates due to adverse events were similar between the two groups.

About BridgeBio Pharma

• Company Overview: BridgeBio Pharma focuses on developing transformative medicines for genetic diseases, with a commitment to applying advances in genetic medicine to benefit patients. Founded in 2015, the company is dedicated to rapid development and delivery of innovative therapies.