CELECOR COMPLETES MULTINATIONAL PHASE 3 REGISTRATIONAL STUDY OF NOVEL ANTI-PLATELET AGENT FOR HEART ATTACK

CeleBrate tested drug designed for rapid treatment at first point of medical contact

DEL MAR, Calif., May 27, 2025 /PRNewswire/ -- CeleCor Therapeutics has completed its multinational Phase 3 clinical trial of Disaggpro™ (zalunfiban), an investigational heart-attack drug designed for rapid use at first point of medical contact – including before patients reach the hospital.

The CeleBrate trial assessed Disaggpro in treating the most severe form of heart attack known as STEMI, in which blood flow to a portion of the heart is almost always cut off by a blood clot. 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.

"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.

"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."

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.¹ Disaggpro was specifically designed for medical first responders and emergency department staff to administer by subcutaneous injection. It reaches maximal effect within 10-15 minutes and has a half-life of about one hour. This makes it a potentially ideal drug to keep blood flowing to the heart in the critical early time period, while not interfering with subsequent in-hospital treatment 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," said Disaggpro inventor Barry Coller, M.D., who is vice president for medical affairs, David Rockefeller Professor, head of the Allen and Frances Adler Laboratory of Blood and Vascular Biology and physician-in-chief 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."

About the CeleBrate study
The CeleBrate study enrolled 2,463 patients at 45 sites in the United States, Canada, Mexico and Europe. The study's Executive Committee included a world-renowned group of health care, regulatory and biostatistics experts, and was chaired by Dr. Gibson.

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 in the ambulance or in a hospital emergency department. The primary efficacy endpoint of the trial is based on a seven-point clinical scale and the primary safety endpoint is to assess bleeding.

"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.

About CeleCor Therapeutics
CeleCor Therapeutics was founded to improve the treatment of ST-segment elevation myocardial infarctions (STEMI heart attacks) at the first point of medical contact. For more updates, follow us on LinkedIn.

¹ Dudas et al, Trends in Out-of-Hospital Deaths Due to Coronary Heart Disease in Sweden (1991 to 2006). Circulation. 2011;123:46-52

CONTACT:
Rob Hillman
[email protected]

SOURCE CeleCor Therapeutics, Inc.