The Food and Drug Administration (FDA) has granted Fast Track designation to coramitug for the treatment of transthyretin amyloidosis cardiomyopathy (ATTR-CM).
Coramitug is an investigational amyloid-depleting therapy that binds to misfolded transthyretin and promotes its removal from the heart through antibody-mediated phagocytosis. The FDA’s Fast Track designation was supported by data from a double-bline, placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT05442047) that included 104 patients with ATTR-CM.
Study participants were randomly assigned 1:1:1 to receive coramitug 10mg/kg, coramitug 60mg/kg or placebo as an intravenous infusion every 4 weeks, in addition to standard of care, for 52 weeks. The coprimary endpoints were the change in the 6-minute walk test (6-MWT) and N-terminal-pro brain natriuretic peptide (NT-proBNP) from baseline to week 52.