BridgeBio Pharma Presents Additional Data and Analyses from its Phase 3 ATTRibute-CM Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at ESC-HF, Including That Acoramidis Treatment Significantly Reduced All-Cause Mortality in a Pre-specified Sensiti
13 Mayo 2024 - 6:30AM
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the
“Company”), a commercial-stage biopharmaceutical company
focused on genetic diseases and cancers, announced positive results
of four new analyses from its Phase 3 ATTRibute-CM study of
acoramidis in ATTR-CM at the European Society of Cardiology (ESC)
Heart Failure Congress 2024. ATTRibute-CM was designed to study the
efficacy and safety of acoramidis, an investigational,
next-generation, orally-administered, highly potent, small molecule
stabilizer of TTR.
The data presented at ESC Heart Failure included a sub-analysis
comparing acoramidis to placebo in Stage 4 CKD and results from a
pre-specified ITT sensitivity analysis shared by Steen Hvitfeldt
Poulsen, M.D., Ph.D., D.M.Sc. of the Aarhus University Hospital,
DK. Key results included:
- In a pre-specified sensitivity analysis applied to the entire
ITT population (N=632), acoramidis significantly reduced all-cause
mortality (ACM) as assessed by the Cochran-Mantel-Haenszel (CMH)
test (p=0.04)
- In high-risk participants with Stage 4 CKD (N=21), acoramidis
treatment was associated with 25% relative risk reduction in deaths
at Month 30 versus placebo, consistent with the observations in the
modified intention-to-treat (mITT) population (N=611)
- No safety signals of potential clinical concern were
identified
“ATTRibute-CM breaks new ground studying the efficacy and safety
of acoramidis, a next-generation TTR stabilizer, as the only
ATTR-CM outcomes trial to include patients with eGFR <25
mL/min/1.73m2,” said Dr. Poulsen. “We recruited patients with Stage
4 CKD (eGFR between 15 and 30 mL/min/1.73m2) to explore the safety
of acoramidis in this very high-risk population; in a pre-specified
all-cause mortality (ACM) efficacy analysis of the total ITT
population including these patients, acoramidis demonstrated a
statistically significant benefit within 30 months. Even in this
very high-risk Stage 4 CKD group, ACM favored active treatment with
no safety signals of clinical concern.”
Additional acoramidis presentations at ESC Heart Failure
included:
- Health-related quality of life in patients with transthyretin
amyloid cardiomyopathy treated with acoramidis: an EQ-5D-5L
analysis from the ATTRibute-CM study, presented by Peter Van Der
Meer, M.D., Ph.D., cardiologist, chair of the Department of
Experimental Cardiology and professor of Heart Failure and
Translational Cardiology at University Medical Centre Groningen, NL
- Acoramidis is the only ATTR-CM product candidate assessed with
the EuroQoL Health Outcomes Assessment tool EQ-5D-5L and
demonstrated a statistically significant and clinically important
reduction in the progressive decline in health-related quality of
life
- Improved health-related quality of life in acoramidis-treated
patients with ATTR-CM, demonstrated by improvements in KCCQ scores,
presented by Marianna Fontana, M.D., Ph.D., Professor of Cardiology
and Honorary Consultant Cardiologist at the National Amyloidosis
Centre, Division of Medicine, University College London, UK
- Acoramidis treatment reduced the decline in health status and
quality of life as shown by statistically significant and
clinically meaningful benefits in the KCCQ overall summary score,
and supported by numerical and consistent benefits in individual
KCCQ domains
- Acoramidis significantly improves NT-proBNP indices that
indicate ATTR-CM disease progression and predict subsequent
mortality: insights from the ATTRibute-CM study, presented by Pablo
Garcia-Pavia, M.D., Ph.D., Iron Gate Majadahonda University
Hospital, ES
- In separate publications, increase in NT-proBNP has been
proposed as a metric signaling disease progression (Progressor
Index 1) and has been shown to predict mortality in wild-type
ATTR-CM at 12 months after diagnosis (Progressor Index 2).
Acoramidis slows disease progression as measured by significant
improvement in these Progressor Indices.
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.
BridgeBio has granted exclusive rights to Bayer to commercialize
acoramidis for ATTR-CM in Europe.
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 and Bayer European License for Acoramidis –
About the Collaboration
In March 2024, BridgeBio granted Bayer exclusive license to
commercialize acoramidis as a treatment for patients with
transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe.
Acoramidis is an investigational, highly potent and selective small
molecule, under development as an orally administered transthyretin
(TTR) stabilizer for the treatment of patients with ATTR-CM a
progressive fatal disease presenting as an infiltrative,
restrictive cardiomyopathy resulting in heart failure.
This partnership leverages Bayer’s long legacy of expertise in
cardiovascular disease and its established European cardiovascular
infrastructure paired with BridgeBio’s leadership in the emerging
field of ATTR-CM.
BridgeBio Forward Looking StatementsThis 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. 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 expectations, plans, and prospects
regarding the success and potential benefits to us of our exclusive
license granted to Bayer to commercialize acoramidis as a treatment
for patients with ATTR-CM in Europe; the clinical, therapeutic and
market potential of our clinical development program for
acoramidis; the potential benefits of acoramidis to ATTR-CM
patients; the statements related to the planned actions and
decisions of the FDA and the EMA regarding our NDA and MAA
submissions for acoramidis for the treatment of ATTR-CM; and the
potential outcomes and expected timing of regulatory reviews by the
FDA and the EMA, 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 preclinical studies and clinical trials not being
indicative of final data, the potential size of the target patient
populations our product candidates are designed to treat not being
as large as anticipated, 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 our regulatory approval strategies, components of our
filings, such as clinical trial designs, conduct and methodologies,
or the sufficiency of data submitted, the continuing success of our
collaborations, including our partnership with Bayer, potential
volatility in our share price, uncertainty regarding any impacts
due to global health emergencies such as COVID-19, including 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 hostilities in Ukraine
and in Israel and the Gaza Strip, increasing rates of inflation and
rising interest rates, on our business operations and expectations,
as 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
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.
BridgeBio Media Contact:Vikram
Balicontact@bridgebio.com (650)-789-8220
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