Zalunfiban improves outcomes in STEMI Patients when given in pre-hospital settings: Phase III Results
The CELEBRATE trial of the novel injectable glycoprotein IIb/IIIa inhibitor zalunfiban (Disaggpro; CeleCor Therapeutics) met its primary safety and efficacy endpoints when administered before hospital admission in STEMI patients, according to top-line phase III results.
The study evaluated whether giving this drug before hospital admission is both safe and effective in improving outcomes for heart attack patients.
At least 50% of heart-attack deaths occur before the patient reaches the hospital. Even as in-hospital treatment for heart attacks has greatly improved, aspirin is the only anti-platelet treatment routinely used in the U.S. for heart attacks before patients can get to the hospital.
Disaggpro was designed to change that, as it can be administered in several pre-hospital settings for rapid treatment of ST-segment elevation (STEMI) heart attacks. The priority in treating STEMI heart attacks is opening the coronary artery as soon as possible after the onset of symptoms to prevent death or irreversible heart damage.
About 40% of heart-attack patients have STEMIs, the most severe form of heart attack, in which blood flow to a portion of the heart is almost always cut off by a blood clot.
Disaggpro is a next-generation investigational GPIIb/IIIa inhibitor that was specifically designed to administer by subcutaneous injection using an auto-injector, allowing a full dose to be contained in a volume of less than 1 milliliter (less than ¼ teaspoon). It reaches maximal effect within 15 minutes and has a pharmacokinetic half-life of about one hour.
About the CeleBrate Study
CeleBrate was a pivotal Phase 3 prospective, double-blinded, randomized, placebo-controlled trial designed to assess the safety and efficacy of a single subcutaneous injection of Disaggpro in STEMI patients in the pre-hospital setting. It enrolled 2,467 patients at 45 sites in the United States, Canada, Mexico and Europe.
