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 knowledge
- The 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.
Webcast InformationBridgeBio 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
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,” “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.
BridgeBio Media Contact:Vikram
Balicontact@bridgebio.com (650)-789-8220
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