'The consistent benefits of acoramidis treatment demonstrated by the ATTRibute-CM results, especially in the context of contemporary ATTR-CM care, are striking and encourage its potential use,' said Professor
The ATTRibute-CM study demonstrated a significant treatment effect of acoramidis in the primary analysis that compared, in a hierarchical manner, all-cause mortality (ACM), cardiovascular-related hospitalization (CVH), N-terminal prohormone of brain natriuretic peptide (NT-proBNP), and 6-minute walk distance (6MWD). Findings presented in the NEJM support acoramidis as an effective and safe treatment option for patients with ATTR-CM and reinforce the hypothesis that greater stabilization of TTR may be associated with improved clinical outcomes. Additional findings in the publication include: The majority of comparisons in the primary hierarchical analysis (58% in the associated
Statistically significant treatment benefit was observed for change from baseline in 6MWD, Kansas City Cardiomyopathy Questionnaire (KCCQ), and serum TTR
The observed 30-month survival rate of 74.3% in the placebo arm of ATTRibute-CM is greater than the observed 30-month survival rate of 70.5% in the combined tafamidis treatment arms of ATTR-ACT, the only previously reported cardiovascular outcomes study in ATTR-CM
As a contemporary benchmark for placing the survival rate of 80.7% in the treatment arm of ATTRibute-CM into context, recent data from the
Similarly, the annualized CVH rate in the treatment arm of ATTRibute-CM of 0.29 can be viewed in the context of data on the annual overall hospitalization rate of 0.26 in the
Serum TTR was promptly and consistently elevated throughout the study in patients receiving acoramidis as a result of near-complete stabilization of the protein
Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified
'These results add to the totality of the available data supporting the concept that the greater the degree of stabilization of tetrameric TTR, the greater the observed clinical benefit,' said
In July, BridgeBio announced positive topline results from ATTRibute-CM. BridgeBio has also presented additional detailed results from ATTRibute-CM at the
The Company submitted a New Drug Application to the
About BridgeBio
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.
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,' '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 planned interactions with regulatory authorities, our intention to submit additional marketing authorization applications in 2024, the statements regarding the potential benefit of our clinical trial or of our product candidate or the potential availability of our product candidate to patients who might benefit from it in the quotes of
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