Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) through Month 42 of the ATTRibute-CM Open Label Extension
- Acoramidis demonstrated a significant reduction in risk of CVM through 42 months post-randomization, with a 44% hazard reduction, setting a new standard for CVM outcomes for patients with ATTR-CM
- Acoramidis also demonstrated a significant 46% hazard reduction in the risk of the composite outcome of CVM or first CVH through 42 months
- Acoramidis demonstrated higher rates of disease stabilization or improvement versus disease progression as compared to placebo as reflected in change from baseline in NT-proBNP and NAC Stage
- In the ATTRibute-CM study, acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date in both ATTRv-CM and ATTRwt-CM patients
- In as few as 3 months, the time to first event (ACM or CVH) durably separated relative to placebo
- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
- Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency and UK Medicines and Healthcare Products Regulatory Agency
PALO ALTO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, presented data from the ATTRibute-CM open label extension (OLE) through Month 42, which demonstrated a statistically significant reduction in CVM in the overall transthyretin amyloid cardiomyopathy (ATTR-CM) population. These data were presented in an oral presentation at the European Society of Cardiology (ESC) Congress 2025, taking place in Madrid, Spain from August 29 - September 1, 2025. Acoramidis is a selective, small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.
"These results from the ATTRibute-CM open-label extension study add to the growing body of evidence supporting acoramidis as a potentially transformative therapy for patients with ATTR-CM. At 42 months post-randomization, acoramidis achieved an impressive 44% reduction in the hazard of cardiovascular mortality. These findings highlight acoramidis's meaningful impact on patient outcomes and address a critical unmet need for those living with ATTR-CM," said Kevin Alexander, M.D. of Stanford University School of Medicine, USA.
Details from the oral presentation, Acoramidis Reduces Cardiovascular Mortality (CVM): Results at Month 42 from the ATTRibute-CM Open-Label Extension (OLE) Study, presented by Dr. Alexander, included:
- Acoramidis treatment administered for 42 months led to a 44% hazard reduction in CVM compared with the placebo to acoramidis treatment group
- These findings demonstrate the long-term clinical benefits of acoramidis for reducing CVM in ATTR-CM, and the importance of early and sustained treatment
In addition to the oral presentation, two posters were shared with additional analyses at 30 month results from ATTRibute-CM. These findings included:
- Acoramidis-mediated Improvement in NT-proBNP at Month 30 Compared with Placebo in Patients with ATTR-CM: Results from the ATTRibute-CM Study, presented by Nitasha Sarswat, M.D. of UChicago Medicine, USA
- Acoramidis treatment resulted in improved or stable N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker used to assess heart failure and monitor its progression, at Month 30 in about 50% of study participants compared with fewer than 20% with placebo, indicating a clinically meaningful improvement in NT-proBNP and better stabilization of their disease
- Acoramidis Has a Beneficial Effect Compared with Placebo on Change from Baseline in NAC ATTR Stage at Month 30 in Patients with ATTR-CM: Results from the ATTRibute-CM Study, presented by Julian Gillmore, M.D., Ph.D., University College London's Centre for Amyloidosis, UK
- Acoramidis treatment resulted in a greater proportion of participants whose NAC Stage, a staging system developed by the National Amyloidosis Centre (NAC) to classify patients based on disease severity, protect against heart damage and improve cardiovascular function improved or remained stable at Month 30 compared with placebo, indicating better stabilization of their disease
Bayer, BridgeBio's European licensing partner, will also have a poster shared by Francesco Cappelli, M.D. of Careggi University Hospital, Florence, IT, showing acoramidis achieved clinically meaningful improvements from baseline in NT-proBNP and/or six-minute walk distance test across 30 months in patients with ATTR-CM. In March 2024, BridgeBio entered into an exclusive licensing agreement with Bayer Consumer Care AG to commercialize BEYONTTRA in Europe for the treatment for ATTR‑CM.
Acoramidis is approved as Attruby by the U.S. FDA and is approved as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and the UK Medicines and Healthcare Products Regulatory Agency with all labels specifying near-complete stabilization of TTR.
More data on the benefit of Attruby for ATTR-CM patients are planned for future medical meetings.
About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio's pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter, Facebook, Instagram, and YouTube.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues," "could," "estimates," "expects," "hopes," "intends," "may," "plans," "projects," "potential," "seeks," "should," "will," and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements regarding the potential of acoramidis as a transformative therapy for patients with ATTR-CM and its potential to result in better stabilization of disease, reflect BridgeBio's current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions it has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies as reflected in or suggested by these forward-looking statements are reasonable, it can give no assurance that such plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to: the risks associated with BridgeBio's dependence on third parties for development; regulatory authorities requiring additional studies or data to support the continued or expanded commercialization of acoramidis; whether data and results meet regulatory requirements or are sufficient for continued development, review, or approval; and whether other regulatory agencies agree with BridgeBio's strategies or data interpretations. These risks also include impacts from global health emergencies, such as delays in regulatory reviews and other activities, manufacturing and supply chain interruptions, adverse effects on healthcare systems, and disruption of the global economy; and the impacts of macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing inflation rates, and fluctuating interest rates on BridgeBio's operations and expectations. Additional risks are described in the Risk Factors section of BridgeBio's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other filings with the U.S. Securities and Exchange Commission. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
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