Coramitug Phase 2 Data Published in Circulation as Novo Nordisk Advances Phase 3 CLEOPATTRA Trial for ATTR Cardiomyopathy
核心洞察
Prothena announced publication of Phase 2 clinical trial data for coramitug, a potential first-in-class amyloid depleter antibody for ATTR amyloidosis (搜索) with cardiomyopathy, in the American Heart Association's journal Circulation.
The Phase 2 results were presented at the AHA Scientific Sessions and support Novo Nordisk's ongoing Phase 3 CLEOPATTRA clinical trial evaluating cardiovascular outcomes in ATTR-CM patients.
Coramitug is being developed by Novo Nordisk as part of their up to $1.2 billion acquisition of Prothena's ATTR amyloidosis (搜索) business, with Prothena eligible for milestone payments including $100 million earned to date.
Prothena Corporation (搜索) announced the publication of Phase 2 clinical trial data for coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for treating ATTR amyloidosis (搜索) with cardiomyopathy (ATTR-CM), in the American Heart Association's journal Circulation. The data supports Novo Nordisk's ongoing Phase 3 CLEOPATTRA clinical trial in patients with this rare cardiac condition.
Phase 2 Results Support Phase 3 Development
The Phase 2 clinical trial results were presented during a late-breaking session at the American Heart Association Scientific Sessions on November 10, 2025, and simultaneously published in Circulation. The study was designed as a randomized, multicenter, double-blind, placebo-controlled trial evaluating coramitug's efficacy in treating transthyretin (搜索) amyloid cardiomyopathy.
Novo Nordisk recently initiated the Phase 3 CLEOPATTRA clinical trial (NCT07207811), which will evaluate the effects of coramitug versus placebo on cardiovascular outcomes in participants with ATTR-CM. The Phase 2 data publication provides scientific foundation for this pivotal study.
Novel Mechanism of Action
Coramitug is an investigational humanized monoclonal antibody designed with a differentiated mechanism of action. The drug is engineered to deplete amyloid associated with disease pathology in both hereditary and wild-type ATTR amyloidosis (搜索), while preserving the native, normal tetrameric form of the transthyretin (搜索) protein.
The proposed mechanism involves depleting both deposited amyloid to improve organ function and circulating non-native TTR (搜索) to prevent further organ deposition. This depleter approach could potentially be developed as a monotherapy for ATTR amyloidosis (搜索) and might complement existing therapeutic approaches that either stabilize or reduce production of the native TTR tetramer.
Strategic Partnership and Financial Terms
Novo Nordisk gained full worldwide rights to the intellectual property and related rights of Prothena's ATTR amyloidosis (搜索) business and pipeline through an acquisition completed 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.
Prothena has earned $100 million to date under this agreement and remains eligible for additional clinical milestone payments when prespecified enrollment criteria are met in the CLEOPATTRA Phase 3 clinical trial.
Company Background
Prothena Corporation (搜索) is a late-stage clinical biotechnology company specializing in protein dysregulation with a pipeline of investigational therapeutics targeting neurodegenerative and rare peripheral amyloid diseases. The company's expertise spans decades of research in neurological dysfunction and the biology of misfolded proteins.
The company's pipeline includes both wholly-owned and partnered programs being developed for diseases including ATTR amyloidosis (搜索) with cardiomyopathy, Alzheimer's disease (搜索), Parkinson's disease (搜索), and other neurodegenerative conditions.