November 13, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
AstraZeneca said today that is conducting a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452, to rapidly and specifically reverse the antiplatelet effects of ticagrelor in emergency situations that cause major bleeding, such a surgery.
That would effectively make MEDI2452 the first medication to reverse the effects of oral antiplatelet agents. The drug is being developed by MedImmune, AstraZeneca’s biologics research and development arm. Ticagrelor will be marketed under the name Brilinta.
“In certain emergencies, doctors need to have the option to swiftly reverse the effects of oral antiplatelet agents, in order to enable emergency surgery or a quick response to a major bleeding event without having to wait for the effects of the medicine to wear off,” said Marc Ditmarsch, global development lead for Brilinta, in a statement. “Currently there are no FDA approved medications to counteract the antiplatelet effect in these situations.”
Brilinta is used to reduce the rate of thrombotic cardiovascular (CV) events in patients with unstable angina, non–ST-elevation myocardial infarction, or ST-elevation myocardial infarction. So far, it has been able to reduce the rate of a combined end point of CV death, myocardial infarction, or stroke compared to competitor clopidogrel.
The difference between treatments was driven by CV death and MI, with no difference in stroke. It also reduces the rate of stent thrombosis in patients treated with percutaneous coronary intervention.
“If the circumstances demand it, we believe MEDI2452 has the potential to help address this need for patients treated with Brilinta,” said Ditmarsch.
The company has been testing ticagrelor in as many situations as possible, as it attempts to hammer out exactly what indications it will ask the U.S. Food and Drug Administration to approve when the drug is ready for federal regulators to examine.
The new pre-clinical program will happen simultaneously with AstraZeneca’s PARTHENON clinical program for ticagrelor, which includes five registration studies involving around 80,000 patients across the broad spectrum of atherothrombotic disease.
Its next study will be the PEGASUS-TIMI 54 study, involving more than 21,000 patients, with top line results expected in the first quarter of 2015. That particular study will test the efficacy and safety of ticagrelor on a background of low-dose aspirin, for the long-term prevention of atherothrombotic events in patients, aged 50 and older, who suffered a heart attack one to three years prior to study enrollment, and who have one additional cardiovascular risk factor.
“Current guidelines generally recommend 12 months of dual antiplatelet therapy following an acute coronary syndrome event, however atherothrombotic disease is a chronic, progressive and in some cases fatal condition,” said Ditmarsch.
“The PEGASUS trial will help us evaluate the potential long-term benefit of therapy with ticagrelor for the chronic condition,” he said. “This will be important information for patients with a history of myocardial infarction and their physicians, to determine the management of their condition following a heart attack beyond 12 months.”
