Acoramidis Associated with First-Ever Early and Sustained Direct Kidney-Protective Effects in ATTR-CM
- Acoramidis initiation was associated with rapid kidney-protective activity as exhibited in a hemodynamically mediated, reversible eGFR dip and a placebo-corrected 15.5% reduction in UACR by Day 28 (P<0.05), with no kidney-related adverse events observed in these post-hoc analyses
-Treatment with acoramidis provided a sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) sustained UACR reduction (13.7%; p=0.026) through Month 30
- Acoramidis demonstrated a profile consistent with drugs that act directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitors, which has not previously been observed with any other approved ATTR-CM therapy and supports a direct kidney mechanism that is potentially independent of TTR-stabilization
-The magnitude of the acute eGFR dip in participants treated with acoramidis was positively associated with a reduction in early cardiovascular outcomes; the opposite was observed with placebo
- The acute, reversible eGFR dip following acoramidis initiation reflects a favorable hemodynamic renal response that may help explain the early separation in cardiovascular outcomes versus placebo. Kidney function is especially important in heart failure, where a progressive decline in kidney function compounds mortality risk
PALO ALTO, Calif., July 02, 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 the publication of new analyses in Circulation: Heart Failure, examining kidney function in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with acoramidis. This publication was based on post-hoc analyses of data from randomized, double blind, placebo-controlled trials including the Phase 2 study and the Phase 3 ATTRibute-CM study. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.
"In these data, we observed early and sustained cardiorenal benefits of acoramidis treatment with a pattern similar to what we see with drugs such as ACE inhibitors, ARBs, and SGLT2 inhibitors, suggesting acoramidis may have a direct effect on kidney function. These effects have not been reported with other ATTR-CM medications. Acoramidis appears to have a protective effect on the heart and the kidney simultaneously, with potentially meaningful implications for long-term survival and reduced cardiovascular hospitalizations. Kidney dysfunction is pervasive in this population and an independent predictor of mortality from ATTR-CM. For a patient population that is older, sicker, and increasingly surviving long enough for organ preservation to matter, these cardiorenal observations represent an important advancement in the care of patients living with ATTR-CM," said Professor Jeffrey Testani, M.D., M.T.R. of the Yale School of Medicine, U.S., and first author on the Circulation: Heart Failure manuscript.
The post-hoc analyses shared in the publication demonstrated that acoramidis initiation was associated with direct kidney-protective effects in patients with ATTR-CM, with both early and sustained improvements in kidney function, resembling the pattern seen with drugs acting directly on the kidney. Findings included:
- Acoramidis was associated with an early, reversible estimated glomerular filtration rate (eGFR) dip of 8.5±0.48 mL/min/1.73 m2 (95% CI: 7.57, 9.44), which was accompanied by a reduction in placebo-corrected urinary albumin to creatinine ratio (UACR) by 15.5% by Day 28 (P<0.05); such a reduction in UACR may suggest a direct impact on kidney health
- A sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) and sustained UACR reduction (13.7%; p=0.026) were observed through Month 30, resembling the pattern seen with drugs acting directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitors
- The acute dip in eGFR following initiation of acoramidis may represent a beneficial kidney effect that could be relevant to the previously reported, observed early separation within the first 3 months between acoramidis and placebo in adverse clinical outcomes and the cumulative cardiovascular-related mortality or recurrent cardiovascular-related hospitalizations (CVH) curves, with a numerical difference in events within 1 month
- Participants with dips larger than the overall population median experienced a 58% lower risk of death or cardiovascular hospitalization (HR: 0.42; 95% CI, 0.22–0.78; P=0.006) and 66% lower risk of hospitalization alone (HR: 0.34; 95% CI, 0.17–0.66; P=0.002) in the first year of treatment. Within the placebo arm, eGFR dips were associated with worse outcomes
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.
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 significance of acoramidis’ observed effects on kidney function, including eGFR and UACR; the potential for acoramidis to have direct kidney-protective effects or a direct effect on kidney function that may be independent of TTR stabilization; the potential relationship between the acute, reversible eGFR dip following initiation of acoramidis and beneficial kidney effects or early separation in cardiovascular outcomes; and the potential implications of these observations for long-term survival and reduced cardiovascular hospitalizations. 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, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the risk that post hoc analyses may not be predictive of future clinical outcomes or treatment effect, that mechanistic interpretations of observed data may not be borne out by further analyses or additional data, and that observed effects on kidney function may not translate into improved long-term clinical outcomes, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, 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
BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
ir@bridgebio.com
