Fast track designation Archives

A clinical-stage biotechnology company that develops therapies for cardiovascular and metabolic diseases today (July 11) announced it has been granted fast track designation by the US Food and Drug Administration (FDA) for a treatment for thrombosis associated with cancer. Anthos Therapeutics focuses on the development and commercialization of drugs and abelacimab is a new, highly selective, fully human, monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation. It does this through Factor XI inhibition and targets the active domain demonstrating dual inhibitory activity and against Factor XI and its activated form, Factor X. Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a phase 3 trial (The ASTER Study). Anticoagulant treatment ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE in whom direct oral anticoagulant treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on day one and subcutaneously monthly thereafter for up to six months; Apixaban 10 mg will be administered orally, twice daily for the first week, followed by 5 mg bid up to six months. Enrollment in this trial began in May 2022. The fast track designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential rolling review, accelerated approval, and priority review. Pulmonary embolism Venous Thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself. However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding. Dan Bloomfield, chief medical officer at Anthos Therapeutics, said: “We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. “This unmet need is particularly true in patients with gastrointestinal or genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need.” Largest program The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2,700 patients across 220 sites in more than 20 countries - the largest program of any anticoagulant performed in this area. Associate professor of hematology at Harvard Medical School, Jean Marie Connors, said: “Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. "Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences. The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward.” The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1,287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia.

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Fast track designation

Treatment for cancer-associated thrombosis fast-tracked by FDA

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