“The promising results from this phase 2 trial requires validation in an adequately-powered phase 3 randomised trial – PHRI’s planned OCEANIC-Stroke… which will investigate the Factor Xa1 inhibitor, asundexian, in addition to antiplatelet treatment for the prevention of ischemic stroke recurrence in patients with non-cardioembolic ischemic stroke and established atherosclerotic disease.”
Also presented at ESC 2022, the PACIFIC-AMI phase 2 trial showed consistent safety results for asundexian comparable to placebo arm, regardless of background therapy, in patients following acute myocardial infarction (AMI).
Previously published data from the PACIFIC-AF (atrial fibrillation) study (Lancet, 2022) further support the hypothesis that asundexian may reduce the risk of thrombotic events without significantly impacting the risk of bleeding.
“Concerns regarding bleeding risk result in the fact that, currently, many patients are treated sub-optimally or not at all”, says Shoamanesh. “In the PACIFIC trials, we saw encouraging bleeding data, suggesting that asundexian may prevent thromboembolic events without a corresponding increase in bleeding risk. If confirmed, asundexian could offer a potential new therapy and help improve patient care.”
Introducing the OCEANIC program
The OCEANIC Phase III clinical development program will start with two large multinational studies, OCEANIC-AF and OCEANIC-Stroke, expected to enroll up to 30,000 patients in over 40 countries.
PHRI”s OCEANIC-Stroke, led by PHRI Scientist Mike Sharma, will be a placebo-controlled study on top of standard of care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. The primary objective of the Phase III study will be to show a lower risk for ischemic stroke in comparison to placebo, without a significant increase in bleeding risk; by selectively modulating coagulation, the once-daily oral FXIa inhibitor asundexian is being investigated as a potential new treatment option in thrombosis prevention.
OCEANIC-AF will test asundexian against apixaban in patients with atrial fibrillation. The primary objective of OCEANIC-AF will be to determine the effects on prevention of stroke and systemic embolism and, in addition, to show a lower risk for bleeding in patients receiving asundexian when compared to patients receiving apixaban. The first patients are expected to be enrolled later this year.