Factor XI

Anthos Therapeutics' Novel Dual-Acting Factor XI/XIa Inhibitor, Abelacimab 150 mg, Demonstrated a 67% Reduction in the Primary Endpoint of Major or Clinically Relevant Non-Major Bleeding Compared with Rivaroxaban in Patients with Atrial Fibrillation

Retrieved on: 
Sunday, November 12, 2023
Biotechnology, Surgery, Health, Pharmaceutical, Clinical Trials, Ruff, Harvard University, Atrial fibrillation, Arrhythmia, Associate, Safety, Therapy, MIT, Factor XI, Risk, AHA, Multimedia, Anticoagulant, Stroke, Heart failure, American Heart Association, Thrombosis, DOAC, Hemostasis, Bleeding, Harvard Medical School, MPH, CDC, Hospital, Ventricular fibrillation, Pharmaceutical industry, Rivaroxaban, Medicine, MD, Brigham, Patient

Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.

Key Points: 
  • Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.
  • Although currently available anticoagulants are effective in preventing strokes in patients with atrial fibrillation, the risk of bleeding remains an issue.
  • “Based on the evidence to date, we are highly confident that abelacimab will offer a potential game-changing treatment approach for patients with atrial fibrillation."
  • Abelacimab is an investigational agent and is not approved for any indication in any country.

Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)

Retrieved on: 
Monday, September 18, 2023
Research, General Health, Pharmaceutical, Oncology, Clinical Trials, Science, Surgery, Cardiology, Biotechnology, FDA, Other Science, Health, VTE, Bleeding, Factor XI, National Blood Clot Alliance, Medicine, Atrial fibrillation, Data monitoring committee, The New England Journal of Medicine, Stroke, Xi, DOAC, Harvard Medical School, CDC, Thrombosis, Anticoagulant, Gold, Coronary thrombosis, Patient, Myocardial infarction, Risk, Rivaroxaban, Thrombolysis, TIMI, Pravastatin or atorvastatin evaluation and infection therapy - thrombolysis in myocardial infarction 22, Hospital, Congress, MPH, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Centers for Disease Control and Prevention, Pharmaceutical industry, Brigham, MD

The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.

Key Points: 
  • The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.
  • In addition, abelacimab is the first and only Factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared to a DOAC, which is the most serious type of bleeding.
  • “The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant.
  • Abelacimab 150 mg maintains ~98% inhibition over the dosing interval, recapitulating the benign bleeding profile of patients with genetic Factor XI deficiency.

Regulatory Authorities in China and Japan Approve Clinical Trials for Anthos Therapeutics’ Dual-Acting Factor XI/XIa Inhibitor Abelacimab

Retrieved on: 
Thursday, June 8, 2023
Medical device, CAT, VTE, Atrial fibrillation, Factor XI, Prevalence, Stroke, Medication, Clinical trial, Cancer, Xi, ASTER, Anthos, Thrombosis, Anticoagulant, Coronary thrombosis, Hemostasis, DSM-IV codes, Patient, PMDA, National Medical Products Administration, AF, FDA, Therapy, Death, NMPA, Pharmaceutical industry

CAMBRIDGE, Mass., June 08, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced two important regulatory milestones in China and Japan for clinical trials of the company’s investigational agent, abelacimab. Abelacimab is a novel, highly selective, dual-acting, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI and Factor XIa inhibition.

Key Points: 
  • Abelacimab is a novel, highly selective, dual-acting, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI and Factor XIa inhibition.
  • In China, the National Medical Products Administration (NMPA) has granted approval for abelacimab to be studied in the ASTER and MAGNOLIA Phase 3 clinical trials which form the Cancer Associated Thrombosis clinical trial program for Anthos.
  • Additionally, the Company received approval to initiate the Phase 3 LILAC-TIMI 76 trial investigating abelacimab in atrial fibrillation (AF) patients deemed unsuitable for current anticoagulants.
  • Abelacimab is an investigational agent that has not been approved for any indication in any country.

Global Hemophilia Treatment Market Report 2022 to 2030 - Featuring Ferring, Kedrion, Octapharma and Novo Nordis Among Others

Retrieved on: 
Thursday, February 2, 2023
World Blood Donor Day, Haemophilia, Coagulopathy, Government, Blood, Diagnosis, VIII, Plasma, Incidence, Research, Risk, Haemophilia B, Male, Haemophilia A, Pregnancy, Growth, Disease, XI, Bleeding, Prevalence, Infection, Factor XI, Pet industry, Vaccine, Pharmaceutical industry, Medical device, Marketing

The global hemophilia treatment market is segmented by hemophilia type into Hemophilia A, Hemophilia B and others.

Key Points: 
  • The global hemophilia treatment market is segmented by hemophilia type into Hemophilia A, Hemophilia B and others.
  • There are two main forms of hemophilia namely Hemophilia A and Hemophilia B. Hemophilia A is approximately four times more prevalent than hemophilia B.
  • The major growth drivers for hemophilia treatment market include rising diagnosis rate, increase focus on prophylactic treatment and development of novel treatment.
  • Hemophilia A is four times more prevalent than hemophilia B and thus dominates the global hemophilia treatment market.

First Patient Enrolled in Phase 3 Trial Evaluating Abelacimab in High-Risk Patients with Atrial Fibrillation Deemed Unsuitable for Current Anticoagulants

Retrieved on: 
Tuesday, January 3, 2023
Thrombolysis, Clinical trial, Anticoagulant, Harvard Medical School, Stroke, Factor XI, Therapy, Hope, Health, Risk, Hemostasis, TIMI, Anthos, Patient, American Foundation for Children with AIDS, Myocardial infarction, AF, Thrombosis, Bleeding, Safety, Kidney, Rivaroxaban, Atrial fibrillation, MPH, Hospital, Pharmaceutical industry, MD, Brigham, Medicine

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that it has enrolled the first patient in LILAC-TIMI 76, a Phase 3 study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation (AF) deemed unsuitable for current anticoagulants by their physician. The study is targeting to enroll approximately 1900 patients from more than 300 sites across North America, Europe, Latin America, and Asia.

Key Points: 
  • The study is targeting to enroll approximately 1900 patients from more than 300 sites across North America, Europe, Latin America, and Asia.
  • Data from multiple registries show that approximately 40% of AF patients are not being optimally treated todayi,” said Dan Bloomfield, M.D., Chief Medical Officer at Anthos.
  • It is an event driven phase 2b study evaluating the safety and tolerability of abelacimab compared head-to-head with rivaroxaban in 1287 patients with atrial fibrillation at moderate-to-high risk of stroke.
  • Anthos is also enrolling patients in GARDENIA, a large international patient registry designed to evaluate treatment patterns and outcomes in segments of the atrial fibrillation population that have conditions associated with an increased risk of bleeding.

Aronora Announces Clinical Data to Be Presented at the 64th American Society of Hematology Annual Meeting

Retrieved on: 
Tuesday, December 6, 2022
National Institute of Allergy and Infectious Diseases, Patient, XII, Safety, National Heart, Lung, and Blood Institute, ASH, Infection, Thrombin, Central line, Factor XII, Lung, FXI, NIH, Factor XI, Society, Therapy, Clinical trial, Pharmaceutical industry, Vaccine, Cancer

PORTLAND, Ore., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Aronora Inc., a clinical-stage biotechnology company developing next-generation therapeutics for blood clotting diseases, announced today that clinical data from a phase 2 study of Gruticibart will be presented at the 64th American Society of Hematology (ASH) Annual Meeting, taking place in New Orleans, Dec. 10-13, 2022.

Key Points: 
  • PORTLAND, Ore., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Aronora Inc., a clinical-stage biotechnology company developing next-generation therapeutics for blood clotting diseases, announced today that clinical data from a phase 2 study of Gruticibart will be presented at the 64th American Society of Hematology (ASH) Annual Meeting, taking place in New Orleans, Dec. 10-13, 2022.
  • Gruticibart (AB023) is a unique recombinant antibody that targets coagulation factor XI (FXI) and specifically inhibits FXI activation by factor XII without blocking its activation by thrombin.
  • It has been specifically designed to treat and prevent blood clots without causing an increased bleeding risk.
  • This content is solely the responsibility of Aronora and does not necessarily represent the official views of the NIH.

Hemophilia Treatment Market Report 2022-2030: Growth Influencers Include Preference for Prophylactic Treatment, Rise in Diagnosis Rate, Significant Rise in Usage of Recombinant Coagulation Factor - ResearchAndMarkets.com

Retrieved on: 
Monday, December 12, 2022
Health, Biotechnology, Degenerative disease, World Blood Donor Day, Haemophilia, Pregnancy, Diagnosis, Plasma, Prevalence, Haemophilia A, Research, XI, Disease, Coagulopathy, Incidence, Haemophilia B, Government, Growth, VIII, Factor XI, Infection, Blood, Risk, Renewable energy, Vaccine, Agriculture, Marketing

The product types studied for analyzing the overall global hemophilia treatment market are majorly segmented into plasma derived coagulation factor concentrates, recombinant coagulation factor concentrates, antifibrinolytic agents and desmopressin.

Key Points: 
  • The product types studied for analyzing the overall global hemophilia treatment market are majorly segmented into plasma derived coagulation factor concentrates, recombinant coagulation factor concentrates, antifibrinolytic agents and desmopressin.
  • The global hemophilia treatment market is segmented by hemophilia type into Hemophilia A, Hemophilia B and others.
  • With increase in healthcare expenditure, preference for prophylactic treatment, rise in diagnosis rate, significant rise in usage of recombinant coagulation factor are major contributors in growth of haemophilia market.
  • Hemophilia A is four times more prevalent than hemophilia B and thus dominates the global hemophilia treatment market.

2022 U.S. Coagulation Testing Market Report: Identify and Evaluate Emerging Business Opportunities - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 1, 2022
Research, Managed Care, General Health, Medical Devices, Hospitals, Health Technology, Clinical Trials, Science, Surgery, Biotechnology, Other Science, Health, ACT, Factor VII, Factor XII, Factor, Factor XI, Factor IX, APTT, Protein S, Activated protein C resistance, Thrombin time, Antithrombin, Bleeding time, Protein C, Factor X, Prothrombin time, Consumables, Factor V, Factor VIII, Prekallikrein, Comparison, Factor XIII, Fibrinogen, Marketing, Retail, Vaccine, Fine chemical, Pharmaceutical industry, Plasmin

The "2022 U.S. Coagulation Testing Market - Analyzers and Consumables - Supplier Shares, Segment Volume and Sales Forecasts for over 40 Assays, Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "2022 U.S. Coagulation Testing Market - Analyzers and Consumables - Supplier Shares, Segment Volume and Sales Forecasts for over 40 Assays, Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • This comprehensive report is designed to help current suppliers and potential market entrants identify and evaluate emerging business opportunities in the US coagulation testing market during the next five years.
  • The report is available by section, and can be customized to specific information needs and budget.
  • The report explores business and technological trends in the US coagulation testing market; provides estimates of the test volume, as well as sales and market shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.

Anthos Therapeutics Announces that Abelacimab Has Received FDA Fast Track Designation for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation

Retrieved on: 
Thursday, September 8, 2022
Program, Research, IV, AF, National Blood Clot Alliance, GLOBE, VTE, Fear, The New England Journal of Medicine, Accelerated approval (FDA), Twitter, Bleeding, Risk, Patient, XI, Cancer, Regulation of tobacco by the U.S. Food and Drug Administration, Fast track (FDA), Incidence, SC, Hope, Apixaban, Food, Factor XI, Sodium, Fast Track, FACC, FDA, Factor, Lists of diseases, Disease, Therapy, Recurrence, Anticoagulant, LinkedIn, Priority review, Stroke, CVM, Anthos, Private Securities Litigation Reform Act, Atrial fibrillation, Review, Mortality, Thrombosis, Pharmacology, Thomas Jefferson University, DOAC, FAHA, White Light Rock & Roll Review, CAT, ASTER, Pharmaceutical industry, Birth control, FHRS, Medicine, MD

CAMBRIDGE, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).

Key Points: 
  • This represents the second Fast Track designation Anthos has received in less than two months, with the FDA also assigning this designation to abelacimab for cancer-associated thrombosis (CAT) in July 2022.
  • Earlier this year, abelacimab also became the first-ever Factor XI inhibitor to begin enrolling patients in Phase 3 trials.
  • As a company, we remain highly committed to working closely with the FDA to bring once-monthly abelacimab to patients in need.
  • Abelacimab, an investigational agent that has not been approved for any indication, received FDA Fast Track designation for the treatment of thrombosis associated with cancer (July 2022) and prevention of stroke and systemic embolism in patients with atrial fibrillation (September 2022).

Bayer Initiates Phase III Study Program for Investigational Oral FXIa Inhibitor Asundexian

Retrieved on: 
Sunday, August 28, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Cardiology, Patient, European Society of Cardiology, Safety, Trust, Program, Proper Dose, Oral, Executive Committee, MacEwen, Proper, Infarction, PMID, Ageing, Disease, Factor XI, S-1 Executive Committee, Science, American College, Xia, Lancet, American College of Cardiology, BAY, Connolly, Blood, Stroke, Nootropic, Group, ESC, Human body, Atrial fibrillation, NOAC, Thrombosis, Growth, ACC, XI, Pharmaceutical industry, Research, Bayer, Brain

The underlying science of FXIa and Phase II PACIFIC data provide a foundation on which to advance asundexian forward into the OCEANIC Phase III program, one of the largest Phase III endeavors Bayer has undertaken.1-2

Key Points: 
  • The underlying science of FXIa and Phase II PACIFIC data provide a foundation on which to advance asundexian forward into the OCEANIC Phase III program, one of the largest Phase III endeavors Bayer has undertaken.1-2
    The PACIFIC clinical trials form part of the broadest Phase IIb FXIa program in the world, involving more than 4,000 patients to date.3-5 The program is part of Bayers commitment to address unmet needs in a growing range of underserved cardiovascular patient communities.
  • Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.
  • Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI).
  • Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.