Anthos Receives Fast Track from FDA for Drug Candidate Targeting AFib Patients - MedCity News

Biotech company Anthos Therapeutics has received US Food and Drug Administration Fast Track designation for abelacimab, a monoclonal antibody, for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Abelacimab inhibits factor XI, which is not required for normal hemostasis or blood clotting, but is very active in causing abnormal blood clots in arteries or veins, which can lead to stroke, said Dr. Dan Bloomfield, chief medical officer of Cambridge, Massachusetts Based Anthos. By inhibiting factor XI, abelacimab is able to prevent the development of abnormal blood clots without affecting the process of generating normal blood clots needed for blood clotting. Abelacimab is expected to be helpful in patients with atrial fibrillation, which is an irregular heart rhythm that creates poor blood flow and can lead to blood clots and strokes.

“When you inhibit factor XI, you don’t disrupt normal clotting, and you can prevent or treat abnormal clots,” Bloomfield said.

Abelacimab differs from current drugs that are factor X or factor Xa inhibitors — such as Xarelto from Bayer and Janssen or Eliquis from Bristol Myers Squibb and Pfizer — which prevent clots from forming but also cause bleeding.

“The key question is can we provide patients with a better and safer anticoagulant to prevent stroke or [deep vein thrombosis],” he said. “So we have to improve what’s already there. What’s already there is very effective, but it causes bleeding.

With the Fast Track designation, Antos will be able to speed up the drug’s development, Bloomfield said. Wellast Track designation is attributed to drugs that treat serious diseases with an unmet medical need. Speeds up the process of getting new medicines to patients.

Antos is in a phase 2 trial for the use of abelacimab to treat patients with atrial fibrillation. The trial completed enrollment in December 2021 with 1,287 patients at 95 global study sites.

This is the second Fast Track designation Antos has received for abelacimab in less than two months. The FDA cleared it for cancer-associated thrombosis (CAT) in July. The therapeutic is also the first factor XI inhibitor to begin enrolling patients in phase 3 trials, the company announced in a news release. The abelacimab phase 3 CAT program has two complementary studies that expect to enroll about 2,700 patients at 220 sites.

Other companies developing factor XI or factor XIa inhibitor therapeutics include Bayer and Merckas well as Bristol Myers Squibb and Jansen, who cooperate. Bayer’s oral drug is a factor XIa inhibitor and is taken once a day. Merck’s is a factor XI inhibitor and is given intravenously with three doses for the first week and one dose per week for the next three weeks. BMS and Janssen’s is a factor XIa inhibitor that is taken orally once or twice daily. Anthos, meanwhile, is a factor XI and factor XIa inhibitor and is given once a month intravenously.

“I would assume for now that they all affect factor XI, it’s just a matter of how much you can inhibit factor XI before you run into a problem,” Bloomfield said.

Photo: metamorworks, Getty Images

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