BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization Events
2024年9月28日 - 7:00AM
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the
“Company”), a commercial-stage biopharmaceutical company
focused on genetic diseases, presented a post-hoc analysis
evaluating the effect of acoramidis on the composite endpoint of
ACM and recurrent CVH events in its Phase 3 ATTRibute-CM study in
ATTR-CM at the Heart Failure Society of America (HFSA) Annual
Scientific Meeting 2024. ATTRibute-CM was designed to evaluate the
efficacy and safety of acoramidis, an investigational,
near-complete, orally-administered, small molecule stabilizer of
TTR.
“We are proud to share the results of this post-hoc analysis
demonstrating a highly significant reduction in all-cause mortality
and the sum of recurrent CV-related hospitalizations in patients
with ATTR-CM at 30 Months in the ATTRibute-CM trial,” said Jonathan
Fox, M.D., Ph.D., chief medical officer of BridgeBio Cardiorenal.
“At BridgeBio, we believe in the importance of both data
transparency and continued communication of additional details of
this landmark trial, especially to assist physicians choosing
ATTR-CM therapies for their patients who rely on their healthcare
provider’s recommendations. By conducting and presenting multiple
analyses, we hope to both advance the clinical science around
ATTR-CM trials and highlight the potential for acoramidis to be a
meaningful treatment option for patients.”
The analysis, shared by Daniel Judge, M.D., professor of
medicine and cardiology at the Medical University of South Carolina
in an oral presentation, included:
- A 42% reduction in composite ACM and recurrent CVH events at 30
months observed with acoramidis treatment compared to placebo by
applying a negative binomial regression model (post-hoc)
(p=0.0005)
- A 42% reduction in the total number of ACM and recurrent CVH
events per patient observed over 30 months with acoramidis
treatment compared to placebo
- A 30.5% hazard reduction in ACM and recurrent CVH events at 30
months observed with acoramidis treatment compared to placebo by
applying the Andersen-Gill model (post-hoc) (p=0.0008)
“This post-hoc analysis provides further evidence that
near-complete TTR stabilization with acoramidis can improve
clinical outcomes for patients with ATTR-CM. The reduction of
hospitalizations and all-cause mortality seen in ATTRibute-CM
heightens the case for acoramidis as a first-line therapy given its
potential to improve the overall quality of life for patients,”
said Dr. Judge.
Additionally, during the Annual Scientific Session of the
Japanese College of Cardiology (JCC), Jin Endo, M.D., Ph.D., Keio
University School of Medicine of Tokyo, Japan presented positive
results from the Phase 3 trial of acoramidis in adults with ATTR-CM
conducted by Alexion, AstraZeneca Rare Disease in Japan, which has
exclusive rights to commercialize acoramidis in Japan. No mortality
was reported over the treatment period of 30 months. Results showed
consistency with the ATTRibute-CM results, including survival, CVH
and other measures of physical function (measured by six-minute
walk test) and quality of life (measured by the Kansas City
Cardiomyopathy Questionnaire Overall Summary Score) at 30
months.
Based on the positive results from ATTRibute-CM, BridgeBio
submitted a New Drug Application to the U.S. Food and Drug
Administration, which has been accepted with a PDUFA action date of
November 29, 2024, and a Marketing Authorization Application to the
European Medicines Agency, with a decision expected in 2025.
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.
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
and Facebook.
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,”
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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 impact of acoramidis on
clinical outcomes, potential benefits of acoramidis, including its
efficacy and potential to improve the quality of life for patients
and the potential outcomes and expected timing of regulatory
reviews by the U.S. Food and Drug Administration and the European
Medicines Agency reflect our current views about our plans,
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and will be affected by a number of risks, uncertainties and
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and/or sales, the U.S. Food and Drug Administration or such other
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the impacts of current macroeconomic and geopolitical events,
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well as those risks set forth in the Risk Factors section of our
most recent Annual Report on Form 10-K 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
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obligation to update publicly any forward-looking statements,
whether as a result of new information, future events or
otherwise.
BridgeBio Media Contact:Vikram
Balicontact@bridgebio.com (650)-789-8220
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