(IN BRIEF) In a Phase III trial conducted in Japan, acoramidis, an investigational treatment for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), demonstrated promising high-level results consistent with the global BridgeBio Pharma, Inc. ATTRibute-CM Phase III trial. The trial in Japan aimed to support local registration and showed improved survival rates, reduced cardiac-related hospitalizations, enhanced functional measures, and improved quality of life for adults with ATTR-CM over a 30-month period. ATTR-CM is a rare, progressive, and fatal condition that often leads to heart failure. Alexion, AstraZeneca Rare Disease, holds an exclusive license for acoramidis in Japan and plans to bring this potential treatment to patients in the country soon. Acoramidis is designed to stabilize transthyretin and preserve native TTR. The trial demonstrated good tolerability and safety, with data to be presented at a future medical meeting and submitted for regulatory review in Japan.
(PRESS RELEASE) CAMBRIDGE, 2-Feb-2024 — /EuropaWire/ — Positive high-level results from the Japan Phase III trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed consistency to those in the global BridgeBio Pharma, Inc. (BridgeBio) ATTRibute-CM Phase III trial (NCT03860935), including survival, cardiac-related hospitalisations 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. 1 This trial in Japan was conducted to support local registration.
ATTR-CM is a rare, systemic, progressive and fatal condition that leads to heart failure and high rates of fatality within four years from diagnosis.2
Alexion, AstraZeneca Rare Disease, maintains an exclusive licence with BridgeBio’s affiliate, Eidos Therapeutics, Inc. to develop and commercialise acoramidis in Japan. The success criterion in the open-label Phase III trial in Japan was defined as greater estimated survival probability at 30 months than that observed among placebo patients in ATTRibute-CM.
Professor Yukio Ando, MD, PhD, Department of Amyloidosis Research, Nagasaki International University, Nagasaki, Japan, said: “As people living with ATTR-CM are at risk of significant morbidity and mortality, including heart failure, halting disease progression is essential to improving outcomes. These results offer further evidence that TTR stabilisation with acoramidis may improve survival and reduce disease severity for patients by preventing further breakdown of these proteins.”
Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: “With one of the industry’s largest amyloidosis pipelines exploring multiple therapeutic modalities, we are working to redefine treatment and care as well as offer new hope for this underserved community. These positive results support our ambition to bring acoramidis to people living with ATTR-CM in Japan as soon as possible.”
Acoramidis is an investigational, next-generation, oral, highly potent small molecule stabiliser of transthyretin, designed to achieve maximal stabilisation and preserve native TTR.3
Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified. The data will be presented at a forthcoming medical meeting and submitted to Japan’s health authority for regulatory review.
Notes
ATTR-CM
ATTR-CM is a progressive, rare, systemic disease caused by ageing or genetic mutations, resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium.4,5 In patients with ATTR, both hereditary and wild type (non-hereditary), TTR protein builds up as fibrils in tissues, such as the peripheral nerves and heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow.4,6 The presence of TTR fibrils interferes with the normal functions of these tissues.5 As the TTR protein fibrils accumulate, more tissue damage occurs and the disease worsens, resulting in poor quality of life and eventually death.5 Worldwide, there are an estimated 300,000 – 500,000 patients with ATTR-CM; however, many of those patients remain undiagnosed.6,7
Phase III Open-Label Trial in Japan
A Phase III, open-label, multicentre, prospective trial (NCT04622046) evaluated the safety and efficacy of acoramidis in Japanese adults with ATTR-CM. This trial enrolled 25 patients in Japan, 22 of which completed the trial at 30 months. Participants were required to have a confirmed diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype and clinical evidence of heart failure. Other requirements included class I-III symptoms due to ATTR-CM in the New York Heart Association Functional Classification.8
Enrolled patients received acoramidis hydrochloride twice daily at a dose of 800 milligrammes for an initial treatment period of 12 months followed by an additional 18 months (for a treatment period of 30 months). The primary endpoints were change from baseline to month 12 in six-minute walk distance, as well as rate of all-cause mortality and frequency of cardiovascular-related hospitalisation over 30 months.8
Statistical analyses were conducted once all participants completed 30 months of active treatment.
Patients who completed 30 months of active treatment were eligible to continue into a long-term extension period, which is ongoing.8
Acoramidis
Acoramidis is an investigational, next-generation, orally-administered, highly potent, small molecule stabiliser of transthyretin (TTR), designed to achieve maximal stabilisation and preserve native TTR.3
Alexion maintains an exclusive licence with BridgeBio’s affiliate, Eidos Therapeutics, Inc., to develop and commercialise acoramidis in Japan.
Alexion
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for more than 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on haematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.
AstraZeneca in Amyloidosis
Amyloidosis is a group of complex rare diseases caused by abnormal proteins that misfold and clump together to form toxic amyloids that deposit in tissues or organs, including the heart, kidneys and peripheral nerves. The build-up of these toxic amyloids can result in significant organ damage and organ failure that can severely impact quality of life and ultimately be fatal. AstraZeneca and its Rare Disease Unit, Alexion, are developing and evaluating multiple modalities with the potential to halt and reduce organ damage across various types of amyloidosis. The Company is uniquely positioned to lead therapeutic and diagnostic advances for people living with amyloidosis with the largest and fastest-growing pipeline of investigational amyloidosis therapies to address the spectrum of patient needs.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.
References
1. Gilmore J, et al. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. N Engl J Med 2024; 390:132-142.
2. Lauppe RE, et al. Nationwide prevalence and characteristics of transthyretin amyloid cardiomyopathy in Sweden. Open Heart. 2021;(2):e001755.
3. BridgeBio News Release: bridgebio announces consistently positive results from phase 3 attribute-cm study of acoramidis for patients with transthyretin amyloid cardiomyopathy (attr-cm). Available here. Accessed January 2024
4. Viney N, et al. Ligand conjugated antisense oligonucleotide for the treatment of transthyretin amyloidosis: preclinical and phase 1 data. ESC Heart Failure. 2021;8(1):652-661.
5. Rintell D, et al. Patient and family experience with transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN) amyloidosis: results of two focus groups. Orphanet J Rare Dis. 2021;16(1):70.
6. Mohamed-Salem L, et al. Prevalence of wild type ATTR assessed as myocardial uptake in bone scan in the elderly population. Int J Cardiol. 2018;270:192-196.
7. Cuscaden C, et al. Estimation of prevalence of transthyretin (ATTR) cardiac amyloidosis in an Australian subpopulation using bone scans with echocardiography and clinical correlation. J Nucl Cardiol. 2021;28(6):2845-2856.
8. ClinicalTrials.gov. A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM. NCT Identifier: NCT04622046. Available here. Accessed January 2024.
Media Contact:
Tel: +44 (0)1223 344 800
email: global-mediateam@astrazeneca.com
SOURCE: AstraZeneca
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- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP