Abelacimab is a dual-acting totally human monoclonal antibody concentrating on each Factor XI and Factor XIa with excessive affinity and selectivity
Earlier this yr abelacimab turned the first-ever Factor XI inhibitor to start enrolling sufferers in a Phase 3 trial (The ASTER Study)
The AZALEA-TIMI 71 trial in sufferers with atrial fibrillation (AF) additionally stays ongoing after having accomplished enrollment with 1,287 sufferers
CAMBRIDGE, Mass., July 11, 2022 /PRNewswire/ — Anthos Therapeutics, a clinical-stage biotechnology firm creating progressive therapies for cardiovascular and metabolic illnesses, at the moment introduced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the therapy of thrombosis related to most cancers. The firm may also be asserting this necessary milestone at the moment at a session of the continued 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.
The Fast Track Designation course of is designed to facilitate the event and expedite the evaluation of therapies for critical medical situations, thereby, addressing unmet medical wants. Drugs which can be included on this program could also be eligible for extra frequent interactions with the FDA to debate the event path, and if this system standards are met, eligibility for a possible Rolling Review, Accelerated Approval, and Priority Review.
Venous Thromboembolism (VTE), together with each deep vein thrombosis and pulmonary embolism, is the second most prevalent explanation for dying in sufferers with most cancers, second solely to the illness itself.1 However, therapy of Cancer Associated Thrombosis (CAT) might be difficult as a result of the at the moment accessible anticoagulants used to deal with VTE can have an elevated danger of bleeding.2,3
“We imagine that abelacimab has the potential to supply sufferers with most cancers related thrombosis an enhanced security profile and total low danger of bleeding, with out sacrificing any efficacy of at the moment accessible brokers. This unmet want is especially true in sufferers with gastrointestinal / genitourinary (GI/GU) cancers who’re at an excellent increased danger of bleeding and might be additional burdened by the inconvenience of every day injections,” mentioned Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics. “Fast monitor designation by the FDA is a big milestone for abelacimab and Anthos Therapeutics, however extra importantly represents one other hopeful step ahead for sufferers. We sit up for working carefully with the FDA on our medical trial program to carry once-monthly abelacimab to sufferers in want.”
“Caring for most cancers sufferers is a fragile and complicated course of, requiring a effective stability between the dangers and advantages of their anticoagulant therapies. Managing thrombosis episodes is of the utmost significance for physicians, sufferers, and their caregivers, as untreated blood clots or bleeding episodes related to at the moment accessible anticoagulants, can have dire penalties,” mentioned Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. “The hemostasis sparing potential of FXI inhibitors, equivalent to abelacimab, could characterize an necessary therapy advance in how we handle sufferers shifting ahead.”
About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)
The abelacimab part 3 CAT program includes two complementary research concentrating on to enroll roughly 2700 sufferers throughout 220 websites in additional than 20 international locations — the biggest program of any anticoagulant carried out in Cancer-Associated Thrombosis.
ASTER is a global multicenter, randomized, open-label, blinded endpoint analysis, part 3 examine evaluating the impact of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in sufferers with most cancers related VTE in whom DOAC therapy is beneficial. Abelacimab 150 mg shall be administered intravenously (IV) on Day 1 and subcutaneously (SC) month-to-month thereafter for as much as 6 months; Apixaban 10 mg shall be administered orally, twice every day (bid) for the primary 7 days, adopted by 5 mg bid as much as 6 months. Enrollment on this trial started in May 2022.
MAGNOLIA is a global multicenter, randomized, open-label, blinded endpoint analysis, part 3 examine in sufferers with gastrointestinal (GI) / genitourinary (GU) most cancers in whom DOAC therapy shouldn’t be beneficial. The examine will examine the impact of abelacimab relative to dalteparin on VTE recurrence and bleeding in sufferers with most cancers related VTE who’re at a excessive bleeding danger with non-resectable, domestically or regionally invasive GI / GU tumors. Abelacimab 150 mg shall be administered intravenously (IV) on Day 1 and subcutaneously (SC) month-to-month thereafter for as much as 6 months; dalteparin administered subcutaneously shall be given every day, 200 IU/kg/day for the primary month, after which 150 IU/kg/day as much as 6 months.
About the AZALEA-TIMI 71 Phase 2 Trial
The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group examine to judge the impact of two blinded doses of abelacimab relative to open label rivaroxaban on the speed of main or clinically related non-major (CRNM) bleeding occasions in sufferers with atrial fibrillation (AF) who’re at moderate-to-high danger of stroke. The trial accomplished enrollment in December 2021, with 1287 sufferers throughout 95 international examine websites together with the U.S., Canada, in addition to from components of Europe, and Asia.
Abelacimab is a novel, extremely selective, totally human monoclonal antibody designed to induce efficient hemostasis-sparing anticoagulation via Factor XI inhibition. Abelacimab targets the energetic area of Factor XI, demonstrating twin inhibitory exercise in opposition to each Factor XI and its activated kind, Factor XIa. Abelacimab might be administered intravenously (IV) to realize speedy inhibition of Factor XI exercise after which used subcutaneously (SC) month-to-month to take care of practically full inhibition in a persistent setting. In a PK/PD examine, abelacimab administered IV offered profound suppression of Factor XI inside one hour after the beginning of remedy and maintained close to maximal inhibition for as much as 30 days. 4,5 In a Phase 2 examine whose outcomes had been revealed within the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgical procedure lowered the speed of venous thromboembolism by 80%, measured 10 days after surgical procedure, in comparison with enoxaparin.4 Factor XI inhibition affords the promise of hemostasis-sparing anticoagulation for the prevention and therapy of arterial and venous thromboembolic occasions.6 Abelacimab is an investigational agent and has not been permitted for any indication.
Fernandes CJ et al. Eur. Resp. Rev. 2019 (https://err.ersjournals.com/content/28/151/180119)
Agnelli G et al. New Engl J Med April 2020 (https://www.nejm.org/doi/full/10.1056/NEJMoa1915103)
Abdol Razak NB et al. Cancers (Basel) Oct. 2018 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209883/)
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Yi BA et al. J Thromb Haemost. Oct. 2021 (https://pubmed.ncbi.nlm.nih.gov/34714969/)
Hsu et al. J Am Coll Cardiol. Aug. 2021 (https://www.sciencedirect.com/science/article/abs/pii/S0735109721053213?via%3Dihub)
About Anthos Therapeutics
Anthos Therapeutics is a clinical-stage biopharmaceutical firm targeted on the event and commercialization of genetically and pharmacologically validated progressive therapies to advance take care of folks residing with cardiovascular and metabolic (CVM) illnesses. Anthos Therapeutics goals to mix the agility of a biotech with the rigor of a giant pharmaceutical firm.
Anthos Therapeutics was launched by Blackstone Life Sciences in 2019.
For extra info go to the web site at https://www.anthostherapeutics.com/, Twitter at https://twitter.com/Anthos_Tx, and LinkedIn at https://www.linkedin.com/company/anthos-therapeutics/.
Forward Looking Statements
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