coramitug (NN6019) / Prothena, Novo Nordisk - LARVOL DELTA

Letter by Dai et al Regarding Article, "Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial". (PubMed, Circulation) - No abstract available

Journal • P2 data • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

Response by Maurer and Fontana to Letter Regarding Article, "Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial". (PubMed, Circulation) - No abstract available

Journal • P2 data • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

Inflammatory Biomarkers In Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Treated With Coramitug: Post Hoc Analysis Of A Phase 2 Randomized Trial [Poster no. 661] (HFSA 2026) - No abstract available

Biomarker • Clinical • P2 data • Retrospective data • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

Effect of coramitug on diuretic use in transthyretin amyloid cardiomyopathy (ATTR CM): a post-hoc analysis from a phase 2 randomised, placebo-controlled study (ESC 2026) - "This exploratory analysis suggests that fewer diuretic dose increases were needed with 60 mg/kg of coramitug. Further, less deterioration of renal function was observed with coramitug 60 mg/kg versus placebo and a subgroup with pre‑existing kidney disease showed a numerical improvement. While needed to be confirmed in larger studies, less diuretic needs might serve as a sensitive surrogate for symptomatic benefit in heart failure."

Clinical • P2 data • Retrospective data • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: Novo Nordisk A/S | Initiation date: May 2026 ➔ Oct 2025

Trial initiation date • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy (Businesswire) - "Novo Nordisk is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029 (NCT07207811)."

Fast track • Trial completion date • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM) (ChiCTR) - P3 | N=1280 | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P3 trial • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis. (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Novo Nordisk A/S

Trial initiation date • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: Novo Nordisk A/S

Trial initiation date • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Transthyretin amyloid depletion therapy: lessons from the phase 2 trial of coramitug. (PubMed, Heart Fail Rev) - "Coramitug was generally well tolerated. These results support continued evaluation in a larger phase 3 trial to determine its clinical efficacy and effect on myocardial function."

Clinical • Journal • P2 data • Review • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis. (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Amyloidosis • Cardiomyopathy • Cardiovascular • CNS Disorders

A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis. (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Amyloidosis • Cardiomyopathy • Cardiovascular • CNS Disorders

NN6019-4958: CLEOPATTRA: A research study to look at the effects of treatment with a medicine called coramitug (NNC6019-0001) in people with heart failure due to ATTR amyloidosis (clinicaltrialsregister.eu) - P2/3 | N=545 | Recruiting | Sponsor: Novo Nordisk A/S

New P2/3 trial • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure

Primary results from the phase 2 randomized, placebo controlled, blinded trial of the monoclonal antibody coramitug in transthyretin amyloid cardiomyopathy (ATTR-CM) (AHA 2025) - "In the first phase 2 trial of an antibody targeting misfolded transthyretin, treatment with the humanized antibody coramitug 60 mg/kg in ATTR-CM was well tolerated and resulted in a statistically significant reduction in NT-proBNP, a validated marker of disease progression."

Clinical • P2 data • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: a Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. (PubMed, Circulation) - "This phase 2 trial showed that coramitug, an antibody targeting misfolded transthyretin in ATTR-CM, was well tolerated and at 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 6MWT within 52 weeks."

Journal • P2 data • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis (clinicaltrials.gov) - P3 | N=1280 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P3 trial • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Prothena Announces that Novo Nordisk Will Advance Coramitug (Formerly PRX004) into Phase 3 Development for ATTR Amyloidosis with Cardiomyopathy (Prothena Press Release) - "Novo Nordisk successfully completed a Phase 2 trial with coramitug and is expected to initiate a Phase 3 program in 2025....Under the terms of the agreement, Prothena is eligible to receive up to $1.2 billion dollars upon achievement of clinical development and sales milestones, including the $100 million earned to date. Prothena is eligible to earn a clinical milestone payment when prespecified enrollment criteria are met in the Phase 3 clinical trial."

Financing • New P3 trial • Amyloidosis • Cardiomyopathy

ATTR CM: A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis (clinicaltrials.gov) - P2 | N=105 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Prothena Announces Corporate Restructuring (Businesswire) - "Company expects initial data in August from Phase 1 ASCENT clinical trials of its wholly owned PRX012 program in Alzheimer’s disease; Novo Nordisk expects to share data from its Phase 2 clinical trial evaluating coramitug for ATTR-CM in the second half of 2025; Company expects to complete a Phase 1 clinical trial for PRX019 in collaboration with Bristol Myers Squibb in 2026."

Clinical data • Trial status • Alzheimer's Disease • Amyloidosis • Cardiomyopathy

Etiological Treatment of Cardiac Amyloidosis: Standard of Care and Future Directions. (PubMed, Curr Heart Fail Rep) - "The standard of care for ATTR-CA include agents capable of selectively stabilizing the precursor protein (e.g., tafamidis), whereas the plasma cell clone is the main target of chemotherapy for AL-CA...Recent data from ATTRibute-CM led to the approval of acoramidis, whereas patisiran received refusal based on the APOLLO-B trial. Novel CRISPR-Cas9-based drugs (i.e., NTLA-2001) hold great potential in the setting of ATTR-CA...However, the investigation of monoclonal antibodies targeting misfolded ATTR (e.g., PRX004, NI301A) or AL (e.g., birtamimab, anselamimab) has led to encouraging results. Various cutting-edge strategies are being tested for treatment of CA and may change the prognostic landscape of this condition in the next years."

Journal • Review • Amyloidosis • Cardiac Amyloidosis • Cardiovascular • Hematological Disorders

Prothena Reports Fourth Quarter and Full Year 2024 Financial Results, and Provides Financial Guidance and Business Highlights (Businesswire) - "PRX019: Phase 1 clinical trial expected to complete in 2026. Birtamimab: The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a statistical significance level of 0.10. Topline results from confirmatory Phase 3 AFFIRM-AL clinical trial expected in 2Q 2025. Coramitug: Phase 2 clinical trial has completed enrollment of approximately 99 patients with trial completion expected in 1H 2025."

P3 data: top line • Trial completion date • Amyloidosis • Cardiomyopathy • CNS Disorders

New therapies to treat cardiac amyloidosis. (PubMed, Curr Opin Cardiol) - "The therapeutic landscape for ATTR-CM and AL-CM is rapidly evolving, driven by novel therapies targeting diverse mechanisms. Ongoing clinical trials promise to further refine the standard of care and improve outcomes for patients with cardiac amyloidosis."

Journal • Amyloidosis • Cardiac Amyloidosis • Cardiovascular

Prothena Reports Third Quarter 2024 Financial Results and Business Highlights (Businesswire) - "'From our wholly-owned programs we expect to complete our confirmatory Phase 3 AFFIRM-AL clinical trial evaluating birtamimab, which is being conducted under a SPA agreement with the FDA at a significance level of 0.10, in 1H 2025. We also expect to announce multiple clinical readouts from our ongoing Phase 1 ASCENT clinical trials evaluating PRX012 for Alzheimer’s disease starting in mid-2025 and continuing throughout the year. In collaboration with Roche, we expect results from the Phase 2b PADOVA clinical trial evaluating prasinezumab for Parkinson’s disease in 4Q 2024 and with Novo Nordisk, we expect results from the Phase 2 signal-detection clinical trial evaluating coramitug for ATTR amyloidosis with cardiomyopathy in 1H 2025.'"

P1 data • P2 data • P2b data • Trial completion • Alzheimer's Disease • Amyloidosis • CNS Disorders • Metabolic Disorders • Parkinson's Disease