Positive Results Reported in CeleBrate Trial of Zalunfiban for STEMI Heart Attacks

CeleCor Therapeutics has announced positive efficacy and safety outcomes from its phase 3 CeleBrate trial of its investigational drug zalunfiban (Disaggpro) in treating patients with ST-segment elevation myocardial infarction (STEMI).

Almost 50% of all heart-attack deaths occur before the patient can reach the hospital. Additionally, roughly 40% of patients experience STEMI, wherein blood flow to a portion of the heart is cut off by a clot. Patients with STEMI have a significantly higher short-term mortality compared to all other patients experiencing heart attacks.1,3

“Disaggpro was designed to change that, as it can be administered in several pre-hospital settings for rapid treatment of STEMI heart attacks,” CeleCor said in a press release. “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.”1

Zalunfiban is a GPIIb/IIIa inhibitor designed for administration via subcutaneous injection using an auto-injector. This allows a full dose to be contained in a volume <1 mL. The drug reaches its maximal effect within 15 minutes and has a pharmacokinetic half-life of about 1 hour.1

CeleBrate was a prospective, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in patients with STEMI heart attacks in a pre-hospital setting. A total of 2467 patients were enrolled at 45 sites across the US, Canada, Mexico, and Europe.1

Participants were evaluated by paramedics during transport to participating hospitals. Patients were included if they had STEMI presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads. Patients were excluded if they required CPR for current Out of Hospital Cardiac Arrest (OHCA), if they presented with systolic blood pressure <90 mmHg and heart rate >100 bpm, were receiving treatment with renal dialysis or oral anticoagulation, had experienced major surgery or trauma or bleeding resulting in hospitalization in the last month, among other conditions.2

Patients were given zalunfiban at either 0.24 mg/lb or 0.29 mg/lb, or placebo. Blood samples were then collected at 1, 6, 24, and 72 hours – or hospital discharge – post-PCI/angiography. Investigators contacted participants at 30 days to report adverse events, bleeding events, and injection site reactions, and at 12 months to record mortality or hospitalization for heart failure or atrial fibrillation.2

According to the press release, CeleCor Therapeutics will present the full results on November 10, 2025, as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans.1

References

1. CeleCor Therapeutics, Inc. Phase 3 Study of Novel Anti-Plaetelet Drug for Heart Attack Reports Positive Topline Results. PR Newswire. September 23, 2025. Accessed September 23, 2025. https://www.prnewswire.com/news-releases/phase-3-study-of-novel-anti-platelet-drug-for-heart-attack-reports-positive-topline-results-302563949.html

2. A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (CELEBRATE). ClinicalTrials.gov identifier: NCT04825743. Updated June 29, 2025. Accessed September 23, 2025. https://clinicaltrials.gov/study/NCT04825743

3. Mitsis A, Gragnano F. Myocardial Infarction with and without ST-segment Elevation: a Contemporary Reappraisal of Similarities and Differences. Curr Cardiol Rev. 2021;17(4):e230421189013. doi:10.2174/1573403X16999201210195702