CeleCor Therapeutics has completed enrollment in its pivotal Phase 3 clinical trial of Disaggpro (zalunfiban), an investigational anti-platelet drug designed to treat heart attacks at the first point of medical contact, including before patients reach the hospital. The CeleBrate trial represents a potential breakthrough in addressing the critical time window for STEMI heart attack treatment, where rapid intervention can mean the difference between life and death.
Addressing Critical Treatment Gap
The CeleBrate study focused on ST-segment elevation myocardial infarctions (STEMI), the most severe form of heart attack where blood flow to a portion of the heart is almost always cut off by a blood clot. While in-hospital management of heart attacks has greatly improved over the past 30 years, at least 50 percent of heart-attack deaths occur before the patient reaches the hospital, highlighting a critical treatment gap that Disaggpro aims to address.
"In a heart attack, the longer the heart artery remains closed, the higher the risk of death and damage to the heart muscle," said C. Michael Gibson, M.D., president & CEO of the Baim Institute for Clinical Research and a professor of medicine at Harvard Medical School. "If we can make heart-attack care more effective at the first point of medical contact, we hope to open arteries earlier and improve the health of these patients."
Novel Drug Design and Mechanism
Disaggpro was specifically designed for medical first responders and emergency department staff to administer by subcutaneous injection. The drug reaches maximal effect within 10-15 minutes and has a half-life of about one hour, making it potentially ideal for keeping blood flowing to the heart during the critical early time period while not interfering with subsequent in-hospital treatments such as stenting or cardiac surgery.
"Disaggpro was designed to act within minutes and to block the receptor platelets use to clump together, so that they cannot start the clotting process," explained Barry Coller, M.D., the drug's inventor and vice president for medical affairs at The Rockefeller University. "For safety, its effects wear off within two hours – when it is no longer needed, because by that time the cardiologists in the hospital will have opened the artery with a balloon and stent."
Clinical Trial Design and Scope
The multinational CeleBrate study enrolled 2,463 patients at 45 sites across the United States, Canada, Mexico and Europe. The pivotal Phase 3 prospective, blinded, randomized, placebo-controlled trial assessed the safety and efficacy of a single subcutaneous injection of zalunfiban in STEMI patients before they reached a cardiac catheterization lab for further treatment.
Eligible STEMI patients were enrolled either in the ambulance or in a hospital emergency department. The primary efficacy endpoint of the trial is based on a seven-point clinical scale, while the primary safety endpoint assesses bleeding complications. The study's Executive Committee included a world-renowned group of healthcare, regulatory and biostatistics experts, chaired by Dr. Gibson.
Clinical Significance and Future Outlook
"This trial really showed that the future of STEMI care is anywhere the STEMI diagnosis can be made very shortly after the onset of symptoms," said CeleBrate principal investigator Professor Arnoud WJ Van 't Hof, M.D., Ph.D., head of interventional cardiology at Maastricht University Medical Center and Zuyderland Medical Center in the Netherlands. "This promising third-generation glycoprotein IIb/IIIa blocker has the potential to become a game changer in this setting."
With enrollment complete, the data will be unblinded and analyzed to determine the study results, which are expected to be released in Q3 2025, followed by presentation at a major medical meeting and publication. Based on the results, filings for marketing approval with regulatory agencies will follow.
"We are excited to have completed the enrollment phase and look forward to the read-out of this landmark trial," said CeleCor CEO Rob Hillman. The company was founded specifically to improve the treatment of STEMI heart attacks at the first point of medical contact, addressing a critical unmet need in cardiovascular emergency care.
