AstraZeneca Begins Pre-Clinical Program For Brilinta Reversal Agent

British drug maker AstraZeneca announced that it has initiated pre-clinical development of an investigational antibody MEDI2452 as a reversal agent for heart drug Brilinta in patients who need urgent surgery or are experiencing a major bleeding event.

MEDI2452 is a neutralizing antibody that binds to ticagrelor and its active metabolite AR-C124910XX in order to reverse its antiplatelet effects. The investigational antibody is being developed by AZ’s global biologics R&D arm, MedImmune. Ticagrelor is an oral antiplatelet drug for acute coronary syndrome (ACS) marketed by AZ as Brilinta. If approved, MEDI2452 would help achieve an antithrombotic effect while also prevent and control excessive bleeding.

“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. Currently there are no FDA approved medications to counteract the antiplatelet effect in these situations. If the circumstances demand it, we believe MEDI2452 has the potential to help address this need for patients treated with BRILINTA,” said Marc Ditmarsch, Global Development Lead for Brilinta.

Reuters reports that developing a reversal agent for Brilinta can help the drug overtake its rivals in the market, which include Sanofi and Bristol-Myers Squibb’s cheaper generic Plavix.

The investigational antibody will be evaluated along with Brilinta in the PEGASUS-TIMI 54 pre-clinical trial, which will involve over 21,000 patients. The study will investigate the safety and efficacy of ticagrelor for the long term prevention of atherothrombotic events in patients 50 years old and above. The company expects topline results from the trial by December or early in January.

The announcement of MED12452’s trial precedes the upcoming American Heart Association (AHA) Scientific Sessions 2014 taking place at Chicago this month. AstraZeneca will present data from its pipeline in metabolic and cardiovascular disease treatments, including Brilinta.