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CeleBrate results presented today at AHA Annual Scientific Sessions

DEL MAR, CALIF., USA – Rapid treatment with CeleCor Therapeutics’ investigational heart-attack drug, zalunfiban, resulted in higher levels of blood flow to the heart and an approximately 21% reduction in a patient’s risk of experiencing a larger MI or one complicated by death, stroke, reinfarction, stent thrombosis or heart failure, new Phase 3 data show.

The results of the pivotal CeleBrate study, which met both its primary efficacy and safety endpoints, were presented today during a late-breaking session at the American Heart Association’s Annual Scientific Sessions in New Orleans. They were published simultaneously in The New England Journal of Medicine Evidence.

CeleBrate involved patients who suffered STEMI (ST-segment elevation) heart attacks – 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. The priority in treating STEMI heart attacks is opening the coronary artery as soon as possible to prevent death or irreversible heart damage.

In the study, zalunfiban was administered at the first point of medical contact – such as in the home, ambulance, or at a hospital emergency department. The study showed that rapid pre hospital treatment with zalunfiban improved and preserved blood flow to the heart until patients could be treated in the cardiac catheterization laboratory.

“The CeleBrate data show that we have the potential to transform how we treat STEMI heart attacks,” 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.

Importantly, zalunfiban treatment did not significantly increase major bleeding, meeting the study’s primary safety endpoint. Minor or moderate bleeding was more common in zalunfiban treated patients, but was not related to long-term outcome and was not associated with mortality in this study.

The need for rapid heart-attack treatment is especially urgent for patients in rural areas or others who don’t live near hospitals with percutaneous coronary intervention (PCI) centers. These patients often experience major treatment delays before they reach the PCI center. In fact, 83% of U.S. STEMI patients who are transferred to a PCI center from another hospital or medical facility don’t get there in time to meet guidelines set by the American Heart Association for effective treatment. This time delay results in a three- to fourfold higher death rate.

Nearly all treated patients in the CeleBrate study did meet the AHA time-to-treatment guidelines, and were given standard-of-care treatment based on best practices in each country.

About 750,000 people in the U.S. each year suffer STEMI heart attacks.¹ The extent of irreversible heart-muscle damage increases with every minute a coronary artery blood vessel remains closed. This damage can later result in heart failure, one of the most common causes of hospitalization and death. By limiting the amount of irreparable damage to the heart, zalunfiban may reduce the risk of developing heart failure immediately and in the long term.

“If zalunfiban is approved by the FDA, we’ll be able to provide rapid, effective treatment for STEMI heart attacks at the first point of medical contact,” said C. Michael Gibson, M.D.,  professor of medicine at Harvard Medical School. “These data show that we can make heart attack care more effective by opening arteries and significantly reducing the risk of severe, irreversible heart damage for those who experience these dangerous events.”

Zalunfiban is a next-generation investigational GPIIb/IIIa inhibitor, the most powerful category of antiplatelet therapies. It was specifically designed for medical first responders and emergency department staff to administer by subcutaneous injection. It reaches maximal effect within 15 minutes, and its effects wear off after about 2 hours.

¹ Reddy A, Ganti L, Banerjee A, Banerjee P. Continuous quality improvement for prehospital STEMI improved triage rates and achievement of gold standard < 90-min EMS-to-balloon time. Int J Emerg Med. 2025 Mar 12;18(1):53. doi: 10.1186/s12245-025- 00863-x. PMID: 40075278; PMCID: PMC11905686.

About the CeleBrate study

CeleBrate was a pivotal Phase 3 prospective, blinded, randomized, placebo-controlled, international multicenter study designed to assess the efficacy and safety of a single subcutaneous injection of zalunfiban in STEMI patients in the pre-hospital setting. It enrolled 2,467 patients at 45 sites in the United States, Canada, Mexico and Europe. More information about the study can be found here

CeleCor plans to file a New Drug Application for zalunfiban with the U.S. Food and Drug Administration in early 2026.

About zalunfiban (Disaggpro™)

Zalunfiban is an investigational agent; it has not been approved for any use and its safety and efficacy have not been established. Zalunfiban is a novel small-molecule inhibitor of the platelet GPIIb/IIIa receptor and was specifically designed for subcutaneous injection at the first point of medical contact for STEMI heart attacks.

GPIIb/IIIa inhibitors are the most potent antiplatelet drugs because they can block platelet aggregation induced by all platelet activators, including thrombin, thromboxane A2 and ADP. Other GPIIb/IIIa inhibitors are not optimal for pre-hospital administration, as they must be given by an intravenous (IV) injection followed by continuous IV delivery using an infusion pump.

“Zalunfiban was designed to be easily administered by a healthcare professional and to act within minutes to block the receptor platelets use to clump together. As a result, the platelets are severely limited in their ability to start the clotting process,” said zalunfiban lead inventor Barry S. Coller, M.D., David Rockefeller Professor, head of the Allen and Frances Adler Laboratory of Blood and Vascular Biology, vice president for medical affairs and physician-in chief at The Rockefeller University.

“Its effects wear off after about two hours – when it is no longer needed, because by that time the cardiologists in the hospital have opened the artery and inserted a stent to keep the artery open,” Dr. Coller said.

MEDIA CONTACT: 
Lisa Guiterman 
202-330-3431 
lisa.guiterman@gmail.com

BUSINESS CONTACT: 
Rob Hillman 
rhillman@celecor.com

DEL MAR, CALIF., USA – CeleCor Therapeutics’ multinational Phase 3 clinical trial of its investigational heart-attack drug Disaggpro^TM (zalunfiban) has shown positive primary efficacy and primary safety outcomes. The full results from the CeleBrate study will be released on Nov. 10 as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans.

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.

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

CeleCor Therapeutics has completed its multinational Phase 3 clinical trial of Disaggpro^TM (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. 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 an 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.”