A new study published in Circulation evaluated whether coramitug, an investigational antibody treatment, could help slow or reverse heart damage caused by transthyretin amyloid cardiomyopathy (ATTR-CM).
ATTR-CM occurs because misfolded transthyretin proteins build up in the heart, making it stiffer and less able to pump effectively. While medications now exist to help slow the production of misfolded proteins, treatments that remove existing amyloid deposits remain limited.
In this phase 2 clinical trial, researchers followed 104 adults living with symptomatic ATTR-CM, including both hereditary and wild-type disease. Participants continued their usual disease-modifying treatment and were randomly assigned to receive coramitug at either 10 mg/kg or 60 mg/kg or a placebo every four weeks for one year.
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Researchers analyzed whether the medication improved levels of a heart stress marker called N-terminal pro-brain typenatriuretic peptide (NT-proBNP), as well as exercise ability, measured by a six-minute walk test.
The higher dose of coramitug achieved a statistically significant reduction in NT-proBNP compared with placebo. This marker is often used to measure strain on the heart, so a decrease may signal improved heart function or reduced disease progression. Imaging tests in this group also found potential structural improvements in the heart, suggesting that the medication may help clear amyloid deposits or reduce their impact.
However, neither dose of coramitug produced a statistically significant improvement in the six‐minute walk test compared to placebo at one year.
The researchers found that coramitug was generally well tolerated, and the frequency of side effects was similar across all groups, including those who received a placebo.
The authors concluded that coramitug at 60 mg/kg produces a meaningful biomarker improvement in NT-proBNP and may drive cardiac structural benefit. They noted this is an encouraging step that justifies the need for larger, longer-term studies looking at outcomes such as hospitalization, quality of life and physical function.
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