BridgeBio Pharma to Present Updated Results from Phase 2 Open-label Extension Study of Acoramidis in Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the American College of Cardiology (ACC) Annual Scientific Session & Expo
BridgeBio Pharma (Nasdaq: BBIO) announced that updated data from its Phase 2 open-label extension study of acoramidis (AG10) for symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) will be presented at the ACC Annual Scientific Session on April 3, 2022. Additionally, the company will address unmet needs in ATTR patient care at the same event. The ongoing Phase 3 ATTRibute-CM study is expected to provide topline data by mid-2023, with a primary endpoint focusing on all-cause mortality and cardiovascular hospitalizations.
- Updated data from the Phase 2 study will be presented at a major conference.
- Ongoing Phase 3 study of acoramidis aims to address significant unmet needs in ATTR treatment.
- Topline data from the Phase 3 ATTRibute-CM study is not expected until mid-2023.
PALO ALTO, Calif., March 28, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in patients with symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) will be featured in an oral presentation at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place in Washington, D.C. on April 2 – 4, 2022.
Additionally at ACC 2022, BridgeBio will share an analysis on the unmet needs in care and quality of life for patients with ATTR to support the Company’s ongoing research to better serve the patient community. Full oral presentation and poster details are listed below.
BridgeBio’s Phase 3 study investigating acoramidis in ATTR-CM (ATTRibute-CM) is ongoing with topline data expected in mid-2023 on the Month 30 primary endpoint, which is a hierarchical composite including all-cause mortality and cardiovascular hospitalizations.
BridgeBio Oral Presentation & Poster Details:
Long-term Safety and Tolerability of Acoramidis (AG10) in Symptomatic Transthyretin Amyloid Cardiomyopathy: Updated Analysis from an Ongoing Phase 2 Open-label Extension Study
Presenter: Ahmad Masri, M.D. MS, director of the cardiac amyloidosis program at Oregon Health & Science University
Date/ Time: April 3, 2022, 8:36 AM - 8:46 AM
Location: Room 204A
Session & Abstract Number: Session 903, Highlighted Original Research: Heart Failure and Cardiomyopathies and the Year in Review; Abstract #903-08
Unmet Needs Among Patients with Transthyretin Amyloidosis (ATTR) and Call for Additional Research
Date/ Time: April 2, 2022, 3:45 PM - 4:30 PM
Location: Poster Hall C
Session & Abstract Number: Session 1364 - Heart Failure and Cardiomyopathies: Population Science 6, Abstract #1364-135
About Acoramidis
Acoramidis (AG10) is an investigational, orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to TTR amyloidosis, or ATTR. Acoramidis is currently being evaluated in Phase 2 and Phase 3 studies in patients with ATTR. Acoramidis was designed to mimic a naturally-occurring variant of the TTR gene (T119M) that is considered a “rescue mutation” because it has been shown to prevent or minimize ATTR in individuals carrying pathogenic, or disease-causing, mutations in the TTR gene. For patients with ATTR, TTR stabilization may/could offer the chance to both preserve the protective benefits of TTR and address the root cause of disease.
About Transthyretin Amyloidosis (ATTR)
Likely affecting more than 400,000 patients globally, ATTR is an underdiagnosed and life-threatening disease with limited treatment options that can devastate the heart and nervous system. When the transthyretin (TTR) becomes unstable due to inherited variants or aging, it can accumulate as amyloid fibrils in various organs in the body, causing ATTR. TTR amyloid deposits predominantly in the heart and/or peripheral nerves, causing cardiomyopathy (ATTR-CM) and/or polyneuropathy (ATTR-PN). ATTR often dramatically impairs the quality of life, functional independence and life expectancy of patients, as well as impacting caregivers due to the progressive nature of the disease. If left untreated, life expectancy from diagnosis is approximately four years.
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 over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company’s first two approved therapies. 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 Statements
This press release contains forward-looking statements. Statements we make 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,” “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 and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to our clinical trial results for Part A of the Phase 3 ATTRibute-CM Study, the prospects of success for Part B results from the Phase 3 ATTRibute-CM Study, the market opportunity for AG10, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these 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, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, our anticipated cash runway, our being fully funded through the completion of the ATTRibute-CM study and our ability to access additional funding upon achievement of portfolio milestones, 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 SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. 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:
Grace Rauh
Grace.rauh@bridgebio.com
(917) 232-5478
BridgeBio Investor Contact:
Katherine Yau
katherine.yau@bridgebio.com
(516) 554-5989
FAQ
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