Prothena Highlights Phase 2 Data for Coramitug (Formerly PRX004) Published in Circulation, Official Journal of AHA
MWN-AI** Summary
Prothena Corporation plc has announced significant advancements concerning coramitug (formerly PRX004), an investigational antibody aiming to treat transthyretin amyloid cardiomyopathy (ATTR-CM). Recently published in the *Circulation* journal of the American Heart Association, the Phase 2 clinical trial data confirms coramitug’s promise as a first-in-class amyloid depleter antibody. The trial results were unveiled during a late-breaking session at the AHA Scientific Sessions on November 10, 2025.
Novo Nordisk, after acquiring Prothena's ATTR amyloidosis business in July 2021 for up to $1.2 billion, has initiated the Phase 3 CLEOPATTRA clinical trial to evaluate coramitug against placebo in patients with ATTR-CM (NCT07207811). Prothena stands to gain significant milestone payments based on the ongoing success of coramitug, having already received $100 million from Novo Nordisk under the acquisition agreement.
Coramitug’s unique mechanism targets amyloid deposits associated with ATTR amyloidosis without affecting the normal tetrameric form of Transthyretin (TTR). It aims to deplete both deposited amyloid to enhance organ function and circulating non-native TTR, potentially improving treatment outcomes as a standalone therapy or as a complement to existing treatments that stabilize or reduce native TTR production.
Prothena, a clinical-stage biotechnology company, is focused on developing therapies addressing protein misfolding and neurodegenerative diseases. Their pipeline extends beyond ATTR amyloidosis to include treatments for diseases such as Alzheimer’s and Parkinson’s. The ongoing developments and positive Phase 2 results signify a promising horizon not only for Prothena but also for patients suffering from ATTR amyloidosis with cardiomyopathy.
MWN-AI** Analysis
The recent publication of Phase 2 data for coramitug (formerly PRX004) in the journal Circulation marks a significant milestone for Prothena Corporation (NASDAQ: PRTA) and its collaboration with Novo Nordisk. The encouraging results from this Phase 2 trial, highlighting coramitug's potential as a first-in-class amyloid depleter for treating ATTR amyloidosis with cardiomyopathy, bode well for the ongoing Phase 3 CLEOPATTRA trial.
Investors should note that the promising data increases the likelihood of regulatory approval, which is pivotal considering Novo Nordisk’s commitment of up to $1.2 billion for Prothena's ATTR pipeline, of which $100 million has already been secured. As Novo Nordisk gears up for Phase 3 trials, achieving the prespecified enrollment criteria will trigger additional milestone payments for Prothena, further enhancing its financial outlook.
Coramitug’s mechanism of action—targeting both deposited amyloid and circulating non-native TTR—differentiates it from existing therapies that primarily stabilize or inhibit native TTR production. This unique approach not only opens avenues for monotherapy but also positions coramitug as a complementary treatment in the broader therapeutic landscape for ATTR amyloidosis, a market expected to grow substantially given rising patient populations.
For investors, Prothena presents a compelling opportunity. The advancing clinical trials around coramitug could significantly enhance its valuation, particularly if the Phase 3 trials yield similarly positive results as seen in Phase 2. However, potential investors should remain cognizant of volatility intrinsic to biotech sectors, particularly as clinical milestones can impact stock price heavily.
Therefore, it is advisable for investors to closely monitor developments regarding coramitug's trial outcomes and regulatory progress, as these will be critical in determining Prothena's trajectory and market position in the coming years.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Novo Nordisk’s Phase 2 data for coramitug supports ongoing Phase 3 CLEOPATTRA clinical trial in patients with ATTR amyloidosis with cardiomyopathy
- Coramitug is being developed by Novo Nordisk as part of their up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline
Prothena Corporation plc (NASDAQ:PRTA) announced the publication of Phase 2 clinical trial data for coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody, for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), in the American Heart Association’s journal, Circulation .
A link to the online publication can be found here:
The Phase 2 clinical trial results were presented during a late-breaking session at the American Heart Association (AHA) Scientific Sessions on November 10, 2025 and simultaneously published in AHA journal, Circulation . 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 ( NCT07207811 ).
Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1.2 billion dollars upon achievement of clinical development and sales milestones, including $100 million earned to date. Prothena is eligible to earn a clinical milestone payment when prespecified enrollment criteria are met in the CLEOPATTRA Phase 3 clinical trial.
About Coramitug (formerly PRX004)
Coramitug (formerly PRX004) is an investigational antibody designed to deplete amyloid associated with disease pathology in hereditary and wild type ATTR amyloidosis, without affecting the native, normal tetrameric form of the protein 2-4 . Coramitug’s proposed mechanism of action is to deplete both the deposited amyloid to improve organ function and circulating non-native TTR to prevent further organ deposition 2-4 . This differentiated depleter mechanism of action could be developed as a monotherapy approach to ATTR amyloidosis and might also complement existing therapeutic approaches which either stabilize or reduce production of the native TTR tetramer 4 .
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design, and proposed mechanism of action coramitug; plans for ongoing and future clinical trials of coramitug; and amounts we might receive under our agreement with Novo Nordisk. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2025, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
References:
1 www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.077304
2 Preclinical studies of PRX004 (coramitug) – data on file
3 Higaki JN et al. Amyloid , 2016
4 Suhr OB et al. Amyloid , 2025
View source version on businesswire.com: https://www.businesswire.com/news/home/20251111691007/en/
Mark Johnson, CFA, Vice President, Investor Relations
650-837-8550
[email protected]
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FAQ**
How does the Phase 2 data for coramitug (Prothena Corporation plc PRTA) support the therapeutic potential of this antibody in treating ATTR-CM compared to existing treatments?
What specific milestones must Prothena Corporation plc PRTA achieve to trigger the potential $1.2 billion payments from Novo Nordisk in relation to coramitug’s clinical development?
Considering the differentiated mechanism of action for coramitug as an amyloid depleter, what are the anticipated advantages over current therapies for ATTR amyloidosis, especially for Prothena Corporation plc PRTA?
How might the outcomes of the Phase 3 CLEOPATTRA trial impact Prothena Corporation plc PRTA’s partnership with Novo Nordisk and future clinical trials for coramitug?
**MWN-AI FAQ is based on asking OpenAI questions about Prothena Corporation plc (NASDAQ: PRTA).
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