– As previously announced, the primary endpoint (a hierarchical analysis inclusive of all-cause mortality and frequency of cardiovascular-related hospitalization) was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001)
– The placebo and acoramidis time-to-first event Kaplan-Meier (K-M) curves for a composite of all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH) separated beginning at Month 3, representing the most rapid & sustained clinical benefit on the composite endpoint of ACM and CVH in ATTR-CM patients through Month 30 (Hazard Ratio = 0.645) to the Company’s knowledge
– Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified
– The Company intends to file a New Drug Application (NDA) for acoramidis with the U.S. Food and Drug Administration (FDA) by end of 2023
PALO ALTO, Calif., Nov. 12, 2023 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today presented additional Phase 3 data from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM, at the American Heart Association (AHA) Scientific Sessions 2023. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). In July, BridgeBio announced positive topline results from ATTRibute-CM, and in August, BridgeBio presented detailed positive results at the European Society of Cardiology Congress 2023. BridgeBio will host an investor call on Sunday, November 12 at 11:15 am ET to discuss these results.
“The positive results of the ATTRibute-CM study demonstrate that acoramidis improved clinical outcomes for ATTR-CM patients, even in the contemporary care setting. The early and sustained benefit on survival and cardiovascular-related hospitalization is remarkable and builds evidence towards the therapeutic hypothesis that near-complete TTR stabilization may improve clinical outcomes for ATTR-CM patients,” said Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina, and co-chair of the ATTRibute-CM Steering Committee.
Improved clinical outcomes from the ATTRibute-CM study at Month 30 included:
A highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001), was observed on the primary endpoint (a hierarchical analysis using the Finkelstein-Schoenfeld test prioritizing in order: ACM, then frequency of CVH, then change from baseline in NT-proBNP, then change from baseline in 6MWD)The K-M composite ACM and CVH Time-to-First Event curves for the treatment and placebo arms separated early, beginning at Month 3, and continued to diverge steadily through Month 30 with a Hazard Ratio of 0.645 (p=0.0008) This represents the most rapid clinical benefit on the composite endpoint of ACM and CVH outcomes in ATTR-CM to the Company’s knowledgeThe Number Needed to Treat (NNT) to avoid a death or first CVH over 30 months was 7
“The results of the current analyses continue to build our confidence that acoramidis has the potential to provide important clinical benefits over current therapeutic options,” said Jonathan Fox, M.D., Ph.D., President, and Chief Medical Officer of BridgeBio Cardiorenal. “In addition to the early benefit on cardiovascular clinical outcomes, we observed an overall 30-month survival in the active treatment arm of ATTRibute-CM of 81%, which should be viewed in the context of the approximately 85% survival rate reported by the U.S. Social Security Administration in an age-matched cohort of the general population. Similarly, we observe that our annualized CV-related hospitalization rate of 0.29 in the acoramidis arm should be viewed in the context of the 0.26 overall hospitalization rate reported by the U.S. Department of Health and Human Services for the general Medicare population.”
The Company intends to submit an NDA for acoramidis to the U.S. FDA before the end of 2023, with regulatory filings in additional markets to follow in 2024. Acoramidis is estimated to have intellectual property protection out to at least 2039.
BridgeBio will host an investor call and simultaneous webcast to discuss the additional clinical outcomes data presented at AHA 2023 for the ATTRibute-CM Phase 3 trial on Sunday, November 12 at 11:15 am ET. A link to the webcast may be accessed from the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.
About BridgeBio Pharma, Inc.
BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. 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 and Twitter.
BridgeBio Pharma, Inc. 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,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “continue,” “will,” and variations of such words or similar expressions. We intend 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 relating to the clinical, therapeutic and market potential of our programs and product candidates, including our clinical development program for acoramidis for patients with transthyretin amyloid cardiomyopathy, the timing and success of our clinical development programs, the progress of our ongoing and planned clinical trials of acoramidis for patients with transthyretin amyloid cardiomyopathy, including our plans to file a new NDA with the FDA by end of year 2023 with regulatory filings in additional markets to follow in 2024, the expected intellectual property protection of acoramidis, our planned interactions with regulatory authorities, the statements regarding the potential clinical benefits or of potential benefits for ATTR-CM patients in the quotes of Dr. Judge and Dr. Fox, and the timing of these events, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, and strategies as reflected in or suggested by those forward-looking statements are reasonable, we 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 our clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, the FDA or other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from the COVID-19 pandemic, hostilities in Ukraine, increasing rates of inflation and rising interest rates, on our overall business operations and expectations, as well as those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2022 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate 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 our 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, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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