Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM

- By Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo

- Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a 49% hazard reduction (p<0.0001)

- The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (95% CI:29–79)

PALO ALTO, Calif., Sept. 28, 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 study showing that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in patients with ATTR-CM. These data were presented in a Late Breaking Clinical Trials Oral Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2025 and simultaneously published in Journal of the American College of Cardiology. Acoramidis is a selective, small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

"Acoramidis demonstrated early and sustained clinical efficacy on the totality of cumulative cardiovascular outcomes, where accrued events start to numerically diverge within the first month of treatment," said Ahmad Masri, M.D., M.S. of Oregon Health & Science University. "As a practicing cardiologist, these findings are incredibly meaningful because it draws attention to the time-sensitive nature of transthyretin amyloidosis diagnosis and treatment initiation, where a safe and effective treatment such as acoramidis can potentially have an early effect on reducing patients' risk of cardiovascular hospitalizations and events."

Details from the late breaking oral presentation, Effect of Acoramidis on Recurrent and Cumulative Cardiovascular Outcomes in ATTR-CM: Exploratory Analysis from ATTRibute-CM, presented by Dr. Masri included:

• At Month 1, numerically fewer cumulative events were observed with acoramidis compared to placebo
• Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH through Month 30 versus placebo with a 49% hazard reduction (p<0.0001)
• The difference in cumulative events increased progressively with results at Month 30 showing 53 events were avoided per 100 treated participants (95% CI:29–79)
• In addition to the late breaking oral presentation, a simultaneous publication in Journal of the American College of Cardiology, with the same title as the presentation, noted the same details and also concluded that at Month 42, CVM was reduced with continuous acoramidis versus placebo-to-acoramidis with a hazard reduction of 45% (p=0.0011)

In addition to the late breaking oral presentation and simultaneous publication of the cumulative cardiovascular outcomes data from ATTRibute-CM, one oral presentation and three poster sessions were shared on the open-label extension data from ATTRibute-CM and real-world evidence. These findings included:

• Continuous Acoramidis Treatment Significantly Reduced Risk of All-cause Mortality and Cardiovascular-related Hospitalization at Month 42, in Patients with Wild-type And Variant Transthyretin Amyloidosis Cardiomyopathy, shared in an oral presentation by Lily Stern, M.D. of Cedars-Sinai Heart Institute
  • At Month 42, continuous acoramidis was associated with lower risk of all-cause mortality (ACM), first CVH, and ACM/first CVH vs placebo to acoramidis switch in both wild-type ATTR-CM and variant ATTR-CM, highlighting the importance of early and continuous acoramidis regardless of TTR genotype
• Acoramidis Mitigates the Rise in NT-proBNP Levels Observed with Placebo in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM, presented in a poster session by Nitasha Sarswat, M.D. of UChicago Medicine
  • In the variant ATTR-CM subpopulation from ATTRibute-CM, acoramidis consistently mitigated the rise in N-terminal pro-B-type natriuretic peptide (NT-proBNP) observed in the placebo variant group, with effects starting at Month 3, and continuing through Month 30. Considering the higher risk posed by variant ATTR-CM, these findings are especially relevant in addressing the distinct medical needs of the variant ATTR-CM patient population
• Effect of Acoramidis on Cardiac Conduction Abnormalities in Transthyretin Amyloid Cardiomyopathy, presented in a poster session by Brett W. Sperry, M.D. of Saint Luke's Health System
  • In ATTRibute-CM, acoramidis treatment was associated with numerically lower percentages of participants with worsening, prolonged PR or QRS intervals at Month 24 and Month 30, compared with placebo. These observations are consistent with the slowing of ATTR-CM disease progression previously reported with acoramidis
• State-Level Differences in Incidence of Transthyretin Amyloid Cardiomyopathy in United States Veterans Persist After Introduction of Disease-Modifying Therapy, presented in a poster session by Sandesh Dev, M.D. of Arizona State University
  • The incidence of ATTR-CM in the U.S. Veteran population increased nationally in the setting of available treatment, possibly due to improved awareness in most states

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 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 Pharma ((BridgeBio, NASDAQ:BBIO) 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 to have an early effect on reducing patients' risk of cardiovascular hospitalizations and events, the timing of future data disclosures, and BridgeBio's ongoing development pipeline, 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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