Additional presentation spotlights GARDENIA registry design in patients
with atrial fibrillation and atrial flutter
Early Cost-Effectiveness Modeling for Patients with Atrial Fibrillation
and Cancer Associated Thrombosis also to be Highlighted
CAMBRIDGE, Mass., May 05, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced today the Company will present four posters at ISPOR—The Professional Society for Health Economics and Outcomes Research’s annual meeting, held in Boston, May 7-10, 2023.
“Patients with the greatest unmet need are at the center of each of our clinical trials we have underway in atrial fibrillation and cancer associated thrombosis, with the sole ambition of improved patient outcomes,” said Dan Bloomfield, M.D., Chief Medical Officer at Anthos. “The data we are presenting at ISPOR will ultimately enhance our understanding of the impact of treating patients with the greatest unmet need as safely and effectively as possible.”
Summary of Abstracts
Title: Design and Rationale of a Global Prospective Observational Study of Real-World Management of Patients with Atrial Fibrillation (AF) at a High Risk of Stroke
Presenter: Sanobar Parkar
Date/Time: May 8, 9:45 am – 1:15 pm, Poster Session 1
Code: CO8
Summary: Researchers will present the trial design for GARDENIA, a global, multicenter, prospective, non-interventional patient registry that will collect real-world clinical data on the utilization of oral anticoagulants in patients with atrial fibrillation or atrial flutter. The study will analyze treatment patterns and outcomes in high-risk AF patients who meet one or more of the following criteria: advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at a higher risk of bleeding. Areas of evaluation include: the factors associated with the decision to treat or not to treat patients with AF with guideline recommended doses of oral anticoagulants; the incidence of all bleeding events in patients with AF who are treated versus those who are not; and the incidence of stroke and systemic embolic events in patients with AF who are treated versus those who are not. The collected real-world data will be used to inform future studies of patients with AF at elevated risk of stroke who are not treated with appropriate oral anticoagulant therapy.
Title: Development of the Anticoagulant Bleeding Burden Adherence Confidence Assessment Scale (ABBA-CAS)
Presenter: Martha Gauthier
Date/Time: May 9, 3:15 pm – 6:45 pm, Poster Session 4
Code: PCR152
Summary: Oral anticoagulants are commonly prescribed to patients with atrial fibrillation (AF) to decrease their risk of stroke and other embolic events. While effective, many patients experience patient-relevant bleeding that is typically not prioritized as part of their care management program. To heighten awareness about what patients are experiencing, the Anticoagulant Bleeding Burden Adherence Confidence Scale (ABBA-CAS) was developed to evaluate patients in three categories: emotional/psychological, physical, and lifestyle/activities of daily living; measures the frequency of oral anticoagulant-related bleeding and bruising and; the severity and frequency of their associated impacts on HRQoL and oral anticoagulant adherence. ABBA-CAS was developed with reference to Food and Drug (FDA) guidance for the development of clinical outcomes assessments.
Title: Cost-Effectiveness of a Novel Treatment for Stroke Prevention in Patients with Atrial Fibrillation (AF): Results from an Early Economic Analysis
Presenter: Jennifer Benner
Date/Time: May 9, 3:15 pm – 6:45 pm, Poster Session 4
Code: EE344
Summary: This early economic analysis explores the potential cost-effectiveness of a hypothetical new therapy that reduces the risk of stroke in patients with atrial fibrillation deemed unsuitable for treatment with currently available anticoagulants. Researchers assessed a plausible range of stroke risk for the new treatment, and total costs and quality-adjusted life years over a lifetime were compared. Considering a range of relative risks of stroke versus usual care, the new treatment remained cost-effective up to a price 2.8 – 14 times higher than apixaban, a commonly prescribed anticoagulant. Researchers found that a new treatment reducing the risk of stroke by at least 9 percent was cost-effective compared with usual care.
Title: Cost-Effectiveness of a Novel Treatment for Cancer-Associated Thrombosis (CAT): Results from an Early Economic Analysis
Presenter: Alexandra Ellis
Date/Time: May 10, 8:30 am – 11:30 am, Poster Session 5
Code: EE504
Summary: A preliminary economic analysis explored the potential cost-effectiveness of a hypothetical new therapy for the treatment of cancer associated thrombosis, compared with apixaban and dalteparin. Researchers assessed a plausible range of bleeding risk for the new treatment, and total costs and quality-adjusted life years over a lifetime were compared. Considering a range of relative risks of bleeding versus apixaban, the new treatment remained cost-effective, with a monthly cost up to 28-53% higher than apixaban. Compared to apixaban, a new treatment that reduced the risk of bleeding by at least 23 percent was cost-effective when assuming the same risk for venous thromboembolism, a 30 percent lower discontinuation rate, and a monthly cost that is 20% higher than apixaban. The new treatment dominated dalteparin in all scenarios explored.
About the GARDENIA Atrial Fibrillation Patient Registry
The GARDENIA patient registry is a global, multicenter, prospective, noninterventional, observational study that will evaluate treatment patterns and outcomes in segments of the atrial fibrillation population that are often not treated with oral anticoagulants or not treated with oral anticoagulants at guideline-recommended doses. The GARDENIA registry is recruiting patients across North America, Europe, and Asia.
About Anthos Therapeutics
Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic (CVM) diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company. Anthos Therapeutics was launched by Blackstone Life Sciences and Novartis in 2019 and has obtained the global rights to develop, manufacture, and commercialize abelacimab (MAA868) under a license agreement with Novartis. For more information, visit the company’s website and follow on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the initiation, and timing, of future clinical trials and its research and development. All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become”, “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
Media Contact
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