Coramitug wins FDA fast track status for rare heart condition

Key Takeaways

• ATTR-CM results from TTR accumulation causing ventricular thickening and diastolic dysfunction, presenting with dyspnea, edema, congestion, tachycardia, and palpitations, with increasing incidence and prevalence in older men.
• Coramitug is a monoclonal antibody engineered to bind non-native, misfolded/aggregated TTR and deplete fibrillar deposits, aiming to improve organ function and reduce circulating pathogenic TTR species.
• Current ATTR-CM standards include TTR stabilizers (acoramidis, tafamidis) and silencers (vutrisiran), while no FDA-approved anti-fibril depleter therapies exist.
• A Novo Nordisk phase 2 study of coramitug 60 mg/kg demonstrated NT-proBNP improvement from baseline, favorable echocardiographic changes, and acceptable tolerability, with results presented at AHA 2025 and published in Circulation.
• The CLEOPATTRA phase 3 program launched October 2025 targets ~1,280 patients, with a primary composite of CV death and recurrent CV events; key secondary endpoints include 6MWT, KCCQ, and all-cause mortality.