Researchers at the American Heart Association’s (AHA) 2025 Scientific Sessions unveiled promising results from Novo Nordisk A/S’s (NYSE:NVO) Phase 2 trial of Coramitug, an innovative treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The trial demonstrated that Coramitug, an antibody designed to target misfolded transthyretin, is well tolerated and can significantly reduce levels of NT-proBNP, a key biomarker for heart failure progression.
In the trial, a dose of 60 mg/kg resulted in a statistically significant reduction in NT-proBNP levels, decreasing by 48% compared to a 22% reduction in the placebo group. Despite these encouraging results, no significant changes were observed in the six-minute walk test (6MWT) over the course of 52 weeks. The findings indicate potential for Coramitug to aid in managing this progressive disease, although further research is necessary to assess its impact on patient functionality.
Coramitug targets the deposition of transthyretin amyloid in the myocardium, the muscular tissue of the heart. By promoting the clearance of misfolded transthyretin through antibody-mediated phagocytosis, it aims to halt disease progression and improve patient outcomes. This treatment was originally developed by Prothena Corporation plc (NASDAQ:PRTA) and acquired by Novo Nordisk in July 2021. Prothena stands to receive up to $1.2 billion based on clinical and sales milestones under the acquisition agreement, including $100 million earned thus far.
The Phase 3 CLEOPATTRA clinical trial has recently begun, further investigating the efficacy of Coramitug compared to placebo in improving cardiovascular outcomes for participants with ATTR-CM. Prothena is also eligible for clinical milestone payments upon achieving specific enrollment criteria in this ongoing study.
The Phase 2 trial included 104 participants, with 90% already undergoing disease-modifying therapies. Of these, 84% were treated with Pfizer Inc.’s (NYSE:PFE) Vyndaqel/Vyndamax (tafamidis), while 7% received therapies from Alnylam Pharmaceuticals, Inc. This diverse background in treatment highlights the trial’s potential impact on various facets of ATTR-CM management.
While Coramitug’s 60 mg/kg dose was associated with improved echocardiographic parameters, its effects on the six-minute walk test did not demonstrate statistical significance when compared to placebo. These results underline the complexities of treating ATTR-CM and the need for continued exploration of treatment strategies.
In response to the study findings, Novo Nordisk’s stock experienced a modest increase of 0.87%, reaching $49.58 during premarket trading on Wednesday. This reflects investor optimism regarding the potential of Coramitug and its implications for heart failure management.
As the research progresses, the medical community will be watching closely to see how Coramitug can contribute to the evolving landscape of therapies for heart failure related to transthyretin amyloidosis. The ongoing trials and the collaborative efforts between Novo Nordisk and Prothena may pave the way for new treatment options for patients facing this challenging condition.
