BridgeBio Pharma Shares Positive Results of Single-Arm Phase 3 Study of Acoramidis in Japanese Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Including No Mortality Reported in the Trial at 30 Months
02 2월 2024 - 9:00PM
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the
“Company”), a commercial-stage biopharmaceutical company
focused on genetic diseases and cancers, today shared positive
results from the Japan Phase III trial of acoramidis in adults with
transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), conducted
by Alexion, AstraZeneca Rare Disease. Results showed consistency to
those in the global BridgeBio ATTRibute-CM Phase III trial
(NCT03860935), including survival, cardiovascular-related
hospitalizations and other measures of improved functions (measured
by six-minute walk test) and quality of life (measured by the
Kansas City Cardiomyopathy Questionnaire Overall Summary Score) at
30 months. This trial in Japan was conducted to support local
registration.
In this single-arm study where patients were on acoramidis
treatment for 30 months, acoramidis was well-tolerated, with no
safety signals of potential clinical concern identified, and no
mortality was reported. The data will be presented at a forthcoming
medical meeting and submitted to Japan’s health authority for
regulatory review.
Alexion, AstraZeneca Rare Disease, maintains an exclusive
license with BridgeBio’s affiliate, Eidos Therapeutics, Inc. to
develop and commercialize acoramidis in Japan. Acoramidis is an
investigational, next-generation, oral, highly potent small
molecule stabilizer of transthyretin (TTR), designed to achieve
maximal stabilization and preserve native TTR.
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 and therapeutic potential of our clinical development
program for acoramidis for patients with transthyretin amyloid
cardiomyopathy, including the plans to present data from the
single-arm, open-label Phase 3 study of acoramidis conducted in
Japan by our partner Alexion, AstraZeneca Rare Disease, at a
forthcoming medical meeting and to submit such data to Japan’s
health authority for regulatory review, 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 the
Middle East and 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
BridgeBio Pharma (NASDAQ:BBIO)
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