CeleCor Therapeutics has announced positive topline results from its multinational Phase 3 clinical trial evaluating Disaggpro (zalunfiban), an investigational antiplatelet drug designed for pre-hospital treatment of ST-segment elevation myocardial infarction (STEMI). The CeleBrate study demonstrated positive primary efficacy and primary safety outcomes, marking a potential breakthrough in emergency cardiac care where treatment options remain severely limited.
The full results from the pivotal trial will be presented on November 10 as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans.
Addressing Critical Treatment Gap
The development of Disaggpro targets a significant unmet medical need in emergency cardiac care. At least 50% of heart-attack deaths occur before patients reach the hospital, yet aspirin remains the only antiplatelet treatment routinely used in the United States for pre-hospital heart attack management, despite substantial improvements in in-hospital treatment protocols.
STEMI represents the most severe form of heart attack, affecting approximately 40% of heart attack patients. In STEMI cases, blood flow to a portion of the heart is almost always completely blocked by a blood clot, making rapid coronary artery reopening critical to prevent death or irreversible cardiac damage.
Novel Drug Design and Mechanism
Disaggpro is a next-generation investigational GPIIb/IIIa inhibitor specifically engineered for pre-hospital administration. The drug's unique formulation allows for subcutaneous injection using an auto-injector, with the full therapeutic dose contained in less than 1 milliliter of volume.
The pharmacokinetic profile of Disaggpro supports its emergency use application, reaching maximal therapeutic effect within 15 minutes of administration and maintaining a pharmacokinetic half-life of approximately one hour. This rapid onset profile is designed to enable treatment across multiple pre-hospital settings where time-critical intervention is essential.
Phase 3 Trial Design and Scope
The CeleBrate study was conducted as a pivotal Phase 3 prospective, double-blinded, randomized, placebo-controlled trial designed to evaluate both safety and efficacy of a single subcutaneous injection of Disaggpro in STEMI patients within pre-hospital settings.
The multinational trial enrolled 2,467 patients across 45 clinical sites spanning the United States, Canada, Mexico, and Europe. Eligible STEMI patients were enrolled in various pre-hospital environments, including at home, in ambulances, or in hospital emergency departments, reflecting the real-world scenarios where such emergency treatment would be most valuable.
The study's design addresses the practical challenges of delivering effective antiplatelet therapy in the critical window between symptom onset and hospital-based interventional procedures, when rapid coronary artery reopening can significantly impact patient outcomes.
