Ionis 与阿斯利康 Wainua 在 ATTR-CM 三期试验未达主要终点

Ionis And AstraZeneca's CARDIO-TTRansform Trial Of Eplontersen In ATTR-CM Misses Primary Endpoint
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By
TajSabreen Ahamed
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Published:
7/9/2026 4:42 AM ET
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Ionis Pharmaceuticals Inc. (
IONS
) and AstraZeneca announced results from the Phase 3 CARDIO-TTRansform trial of Eplontersen in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). The study did not meet its primary endpoint, a composite of cardiovascular mortality and recurrent cardiovascular events through Week 140 compared with placebo.
Understanding ATTR-CM
ATTR-CM is a progressive, life-threatening condition caused by misfolded transthyretin protein deposits in the heart, leading to heart failure and reduced quality of life. With an estimated 300,000 to 500,000 patients worldwide, earlier diagnosis and targeted therapies remain critical.
Subgroup Findings
In a prespecified subgroup analysis, patients treated with Eplontersen monotherapy showed a nominally significant hazard ratio of 0.71 for reduced cardiovascular mortality and recurrent events compared to placebo. No treatment effect was observed in patients already receiving stabilizer therapy at baseline. Secondary imaging and biomarker analyses favored Eplontersen, with large and sustained reductions in transthyretin levels consistent with RNA silencer therapies.
Safety Profile
Eplontersen was well tolerated, with a safety profile consistent with prior studies. Ionis CEO Brett Monia acknowledged disappointment at missing the primary endpoint but emphasized that the findings provide clarity for the evolving treatment landscape, where stabilizer use is widespread.
Trial Design
CARDIO-TTRansform enrolled 1,432 patients across 130 sites in 20 countries, making it the largest ATTR-CM trial to date. Participants were randomized to receive Eplontersen 45 mg or placebo every four weeks, with secondary endpoints including six-minute walk distance, quality-of-life scores, and all-cause mortality.
Next Steps
Ionis and AstraZeneca plan to present the full dataset at the European Society of Cardiology (ESC) Congress in August 2026.
AZN has traded between $137.22 and $212.71 over the past year. The stock closed Wednesday's trading at $189.28, down 1.99%. In pre-market trading the stock is at $174.15, down 7.97%.
For comments and feedback contact: editorial@rttnews.com
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