With new phase 3 data backing the ability of its emergency use zalunfiban to fend off further heart damage, CeleCor Therapeutics is one step closer to bringing a speedy new weapon to the race against time that is medical care for heart attacks.
CeleCor’s zalunfiban, an investigational antiplatelet therapy that blocks the glycoprotein IIb/IIIa receptor, is designed to be administered by first responders and emergency departments as the first point of medical contact for patients with suspected segment elevation myocardial infarction (STEMI) heart attacks. The subcutaneous injection has the potential to "transform how we treat STEMI heart attacks,” principal trial investigator Arnoud WJ van 't Hof, M.D., Ph.D., said in a Nov. 10 press release.
The company assessed the drug in its CeleBrate study, details from which were reported in a late-breaking session at the American Heart Association’s annual scientific sessions in New Orleans. The results were also published in NEJM Evidence.
When administrated at the first point of medical contact, zalunfiban prompted higher levels of blood flow to the heart and a 21% reduction in the risk of a larger heart attack or one that leads to death, stroke, heart failure or other risks compared to placebo, according to CeleCor.
As well as succeeding on its efficacy endpoints, the drug also hit on safety, as it didn’t significantly increase major bleeding. With the CeleBrate data in hand, CeleCor looks to file its prospect for FDA approval in early 2026, the company said.
About 750,000 people in the U.S. each year experience STEMI heart attacks, which are the most severe form of heart attack and are caused by blood clots that block blood flow to a portion of the heart. Typically, emergency care for this heart attack centers on opening the coronary artery as soon as possible to prevent death or irreversible heart damage.
However, the urgency this procedure necessitates poses a problem for those who live in rural areas or otherwise don’t have a hospital with a percutaneous coronary intervention (PCI) nearby. Eighty-three percent of U.S. STEMI patients who are transferred to a PCI center from another hospital don’t arrive in time to receive effective treatment, making for a three- to fourfold higher death rate, according to CeleCor.
Each minute that a coronary artery blood vessel remains closed heightens the risk of irreversible damage to the heart muscle, which can later result in heart failure.
Zalunfiban, meanwhile, reaches its maximal effect within 15 minutes and wears off in about two hours. By the time the drug does wear off, 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,” Rockefeller University’s vice president for medical affairs Barry S. Coller, M.D., explained.
Coller invented zalunfiban and co-founded CeleCor in 2017 with the sole purpose of improving the treatment of STEMI heart attacks.