Acoramidis Continues to Demonstrate Disease-Modifying Effects in ATTR-CM, Reducing sTTR Variability and Outpatient Worsening Heart Failure
-Acoramidis increased sTTR early and significantly reduced intra-individual sTTR variability versus placebo (p<0.001), which is associated with reduced ACM, further reinforcing its differentiated profile in ATTR-CM
-Acoramidis further demonstrated early separation of outpatient worsening heart failure seen within 30 days and sustained through Month 30, showing the fastest time to impact of any disease modifying treatment in ATTR-CM
-Acoramidis demonstrated a statistically significant, clinically meaningful 34% reduction in cardiovascular hospitalizations versus tafamidis in a matching-adjusted indirect comparison, with a favorable mortality trend and comparable safety
PALO ALTO, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced new data from the Phase 3 ATTRibute-CM study at Heart Failure 2026, organized by the Heart Failure Association of the European Society of Cardiology (ESC-HF), further demonstrating acoramidis' consistent and clinically meaningful benefit across the transthyretin amyloid cardiomyopathy (ATTR-CM) disease spectrum, with new data demonstrating disease modifying effects across clinical outcomes, biomarkers, and functional capacity. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.
In a late-breaking oral presentation shared by Senthil Selvaraj, M.D. of Duke University School of Medicine, U.S., acoramidis showed an association between the treatment-related increase in serum transthyretin (sTTR) and a significant reduction of sTTR variability over time, which is independently associated with reduced all-cause mortality (ACM). Findings included:
- Lower intraindividual sTTR variability and higher achieved sTTR levels were each independently associated with reduced risk of all-cause mortality (HR: 0.56; p=0.014 and HR: 0.46; p=0.014, respectively)
- Participants with both higher achieved sTTR levels and less variable sTTR levels experienced the greatest survival benefit, while higher sTTR variability was associated with adverse clinical features of ATTR-CM
- Acoramidis increased sTTR levels early (Day 28) and sustained them through Month 30, while significantly reducing sTTR variability versus placebo (9.5% vs. 12.8%; p<0.001)
- Reduction in sTTR variability mediated 20% of acoramidis' treatment effect on mortality
"While increasing TTR levels on stabilizer therapy is important and strongly relates to risk of dying in ATTR-CM, these new results demonstrate that reducing TTR variability at the individual level over time also seems to be important for modifying disease outcomes. Acoramidis not only rapidly increases TTR levels, but significantly decreased this variability compared with placebo. By linking TTR variability independently to mortality, we're seeing a mechanistic signal that may help explain acoramidis' clinical benefit, providing complementary data to support its use in ATTR-CM," said Dr. Selvaraj
Additionally, Bayer, BridgeBio's exclusive European licensing partner of acoramidis, presented a late-breaking oral presentation by Marianna Fontana, M.D. of University College London, UK, showing that acoramidis drove early and sustained reductions in the risk of outpatient worsening heart failure within 30 days. These findings included:
- Acoramidis reduced the risk of outpatient worsening heart failure versus placebo by 41% (HR 0.59, 95% CI 0.46–0.75; p < 0.0001, with K-M curve separation seen within 30 days and sustained through Month 30)
- Outpatient worsening heart failure was a strong predictor of mortality and cardiovascular hospitalizations, reinforcing its role as an early and clinically meaningful marker of disease progression
- Even after adjusting for outpatient worsening heart failure, acoramidis reduced risk of mortality and recurrent cardiovascular hospitalizations by 41% (HR 0.59, 95% CI 0.45–0.77; p = 0.0001)
For the first time, BridgeBio also shared an anchored matching-adjusted indirect comparison presented by Emer Joyce, M.D., Ph.D. of the Mater Misericordiae University Hospital, IE, of acoramidis versus tafamidis using the pivotal study data with statistically significant, clinically meaningful benefit, which showed that:
- Acoramidis demonstrated a statistically significant, 34% reduction in cardiovascular hospitalizations versus tafamidis (RRR: 0.66; 95% CI: 0.46–0.95)
- Acoramidis showed a favorable mortality trend with 28% hazard reduction in all-cause mortality versus tafamidis, with consistent benefit across sensitivity analyses
- Comparable safety profile observed between acoramidis and tafamidis
In addition to the presentations highlighted, three additional acoramidis posters were also shared at Heart Failure 2026, which included:
- Acoramidis Treatment Attenuates the Rise in NT-proBNP from Baseline to Month 30 Compared to Placebo Across all Subgroups, presented by Marianna Fontana, M.D., of University College London, UK
- In ATTRibute-CM, acoramidis consistently blunted the 30-month increase in NT-proBNP by about 50% across all participant subgroups assessed, including advanced disease, compared with placebo, demonstrating its robust efficacy on a key biomarker of ATTR-CM disease progression
- Consistent Benefit on Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) with Acoramidis Treatment Compared with Placebo Across Participant Subgroups in ATTRibute-CM, presented by Dr. Fontana
- Acoramidis significantly attenuated the decline in heart failure-related health status compared with placebo in individuals with ATTR-CM. This effect was observed consistently across all pre-specified participant subgroups, including those with advanced heart failure symptoms
- Effect of Acoramidis on Improvement or Maintenance of Heart Failure-Related Health Status as Assessed by KCCQ-OS Score in ATTRibute-CM, presented by Charles Sherrod, M.D. of Saint Luke's Health System, Kansas City, U.S.
- In individuals with ATTR-CM, acoramidis treatment was associated with a significantly greater likelihood of maintenance or improvement in health status compared with placebo, suggesting a clinically relevant modification of disease trajectory. These data provide an integrated assessment of health status and survival to inform medical decision making
Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.
Additional data on the benefit of Attruby for individuals with ATTR-CM is 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
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
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," "estimates," "expects," "hopes," "intends," "may," "plans," "projects," "remains," "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 include statements regarding the potential clinical and disease-modifying benefits of acoramidis; the potential significance of acoramidis' observed impact on sTTR levels and sTTR variability over time, outpatient worsening heart failure, and other clinical outcomes; the potential relationship between such biomarker and clinical findings and reduced mortality or hospitalization risk; acoramidis' potential comparative performance versus tafamidis, including with respect to cardiovascular hospitalizations and mortality trends. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the 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 risk that analyses of biomarker data, outpatient worsening heart failure events, mortality trends, mediation analyses or indirect comparisons may not be predictive of future clinical outcomes or treatment effect; that additional analyses or data may differ from the results described in this press release; that cross-trial or matching-adjusted indirect comparisons are subject to important limitations and assumptions; future regulatory filings, approvals and/or sales, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission. Moreover, the Company 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 the Company'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 the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President
contact@bridgebio.com
(650)-789-8220
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ir@bridgebio.com
