The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack involving up to 30,000 patients / Bayer drives the development of its FXIa inhibitor, with the goal of offering a potential new class of antithrombotics for improved outcomes for patients using selective coagulation modulation
Bayer blazoned moment the launch of a Phase III clinical development program “ OCEANIC ” to probe the efficacity and safety of asundexian, an oral Factor XIa( FXIa) asset, as a implicit new treatment in cases with atrial fibrillation and in cases with anon-cardioembolic ischemic stroke or high- threat flash ischemic attack.
Factor XI is a protein in the blood which is converted into its active enzyme form( Factor XIa) as part of the blood coagulation waterfall. Factor XI is a promising and discerned target for the development of safer anticoagulants because of its critical part in pathological versus normal thrombus conformation sundering hemostasis from thrombosis. Cases with natural Factor XI inheritable insufficiency demonstrate a lower threat for venous thromboembolism and ischemic stroke but infrequently have robotic bleeding.
1 The OCEANIC program is designed to assess the eventuality of asundexian to cover cases from pathological thrombus conformation without a corresponding increase in bleeding threat aiming to ameliorate the benefit- threat profile compared to current treatment options. FXIa impediments that widely modulate coagulation through FXIa inhibition could represent a unnaturally new approach to antithrombotic treatment, as they help thrombosis yet still allow haemostatic clots that are pivotal to repair injury.
The inauguration of the OCEANIC program is grounded on the data from the Phase II PACIFIC program. The PACIFIC- STROKE2 and PACIFIC- AMI3 Phase IIb trials compared the safety and efficacity of asundexian with placebo in cases following acutenon-cardioembolic ischemic stroke or acute myocardial infarction( AMI), independently. Both trials showed harmonious safety results for asundexian similar to placebo arm, anyhow of background remedy.
The data from the completed PACIFIC Phase IIb clinical trial program, including preliminarily published data from the PACIFIC- AF4( atrial fibrillation) study, farther support the thesis that asundexian may reduce the threat of thrombotic events without significantly impacting the threat of bleeding.
“ enterprises regarding bleeding threat result in the fact that, presently, numerous cases are treatedsub-optimally or not at all ”, saidDr. Ashkan Shoamanesh, Associate Professor of Medicine( Neurology) at McMaster University. “ In the PACIFIC trials, we saw encouraging bleeding data, suggesting that asundexian may help thromboembolic events without a corresponding increase in bleedingrisk.However, asundexian could offer a implicit new remedy and help ameliorate patient care, If verified. ”
“ We’ve had significant advances for our cases taking anticoagulation with the preface of the direct oral anticoagulants. But we still have cases who don’t get the remedy, or for whom there’s a need for indispensable treatment options in thrombosis forestallment, ” said Manesh Patel, RichardS. Stack Distinguished Professor, Chief of the Division of Cardiology andCo-Director of the Heart Center at Duke University. “ The Phase III OCEANIC program is the essential coming step to induce further data for asundexian as a implicit new treatment option for this large complaint area. ”
The OCEANIC Phase III clinical development program will start with two large transnational studies, OCEANIC- AF and OCEANIC- STROKE, anticipated to enroll up to,000 cases in over 40 countries.
OCEANIC- AF will test asundexian against apixaban in cases with atrial fibrillation. The primary ideal of OCEANIC- AF is to determine the goods on forestallment of stroke and systemic embolism and, in addition, to show a lower threat for bleeding in cases entering asundexian when compared to cases entering apixaban. The first cases are anticipated to be enrolled latterly this time.
About the PACIFIC- AMI trial3
PACIFIC- AMI was amulti-center, randomized, placebo- controlled, double-eyeless parallel- group, Phase IIb cure- chancing trial to estimate the safety and efficacity of asundexian in cases following an AMI. The trial compared asundexian 10 mg, 20 mg or 50 mg oral tablets taken formerly a day versus placebo on top of standard of care binary antiplatelet remedy( DAPT). The primary efficacity endpoint was the compound of CV death, myocardial infarction( MI), stroke and stent thrombosis and the primary safety endpoint was Bleeding Academic Research Consortium( BARC) bleeding description type 2, 3 and 5. 1601 cases were randomized into the trial across 157 spots and 23 countries.
All cases were initiated on treatment within 5 days of hospitalization for the indicator AMI event and continued treatment for 26 to 52 weeks. Asundexian was well- permitted with similar safety data, including bleeding, versus the placebo arm when combined with binary antiplatelet remedy( DAPT). The trial wasn’t powered to test for differences in thrombotic events. The PACIFIC- AMI trial results were contemporaneously published online moment in the journal Rotation.
About Asundexian and FXIa Impediments
FXIa inhibition specifically targets a protein involved in pathological thrombus conformation but leaves the pathway involved in physiological mending of vessel wall injuries complete. By widely modulating the coagulation system, asundexian may offer the eventuality to help events like stroke and acute myocardial infarction( AMI) without a corresponding increase in bleeding threat. Asundexian is presently being estimated as a potentially bettered treatment option in thrombosis forestallment. Asundexian is a formerly- daily, oral investigational agent and has not been approved by any health authority for use in any country, for any suggestion.
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