In a presentation at the American Heart Association's (AHA's) 2025 Scientific Sessions, researchers on Tuesday shared data from Novo Nordisk A/S' (NYSE:NVO) Coramitug Phase 2 trial for transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

Data

The phase 2 trial showed that coramitug, an antibody targeting misfolded transthyretin in ATTR-CM, was well tolerated.

A dose of 60 mg/kg resulted in a statistically significant reduction in NT-proBNP, a validated marker of disease progression, with no statistically significant effect on the six-minute walk test (6MWT) within 52 weeks.

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ATTR-CM is a progressive disease caused by the deposition of transthyretin as amyloid in the myocardium (the muscular tissue of the heart).

Coramitug is a humanized monoclonal antibody that targets misfolded transthyretin, designed to promote clearance of transthyretin amyloid through antibody-mediated phagocytosis.

Background

Coramitug was initially developed by Prothena Corporation plc (NASDAQ:PRTA) and was acquired by Novo Nordisk in July 2021.

Under the terms of the agreement, Prothena is eligible to receive up to $1.2 billion upon achievement of clinical development and sales milestones, including the $100 million earned to date.

Novo Nordisk recently initiated the Phase 3 CLEOPATTRA clinical trial evaluating the effects of coramitug versus placebo on cardiovascular outcomes in participants with ATTR-CM.

Prothena is eligible to earn a clinical milestone payment when prespecified enrollment criteria are met in the CLEOPATTRA Phase 3 clinical trial.

In total, 104 participants were randomized and dosed.

90% of participants were on disease-modifying therapy; 84% were treated with Pfizer Inc.'s (NYSE:PFE) Vyndaqel/Vyndamax (tafamidis), and 7 with Alnylam Pharmaceuticals, Inc.'s (NASDAQ:ALNY) TTR silencers (patisiran, n=4; vutrisiran, n=3).

From baseline to week 52, coramitug 60 mg/kg significantly reduced NT-proBNP levels compared with placebo (–48%, –22%).

The change in 6MWT from baseline to week 52 was not statistically different from placebo with either dose. Coramitug 60 mg/kg was associated with improved functional echocardiographic parameters and was well tolerated.

Price Action: NVO stock is up 0.87% at $49.58 during the premarket session at the last check on Wednesday.

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