The drug met primary safety and efficacy outcomes, with full results to be presented at the AHA Scientific Sessions.
The CELEBRATE trial testing the novel injectable glycoprotein IIb/IIIa inhibitor zalunfiban ( Disaggpro; CeleCor Therapeutics) before hospital admission in STEMI patients has met its primary safety and efficacy endpoints in a phase III study, according to top-line results announced by the manufacturer today.
As a small molecule inhibitor, zalunfiban was developed to facilitate prehospital antiplatelet therapy and improve coronary reperfusion. The drug begins to work in less than 15 minutes and has a half-life of approximately 1 to 2 hours. An earlier phase IIa study, reported by TCTMD, showed that treatment with zalunfiban results in rapid and potent platelet inhibition in STEMI patients, while also being well tolerated.
For the trial, 2,467 patients with persistent ischemic chest pain (< 4 hours) were randomized 1:1:1 to zalunfiban 0.110 mg/kg, 0.130 mg/kg, or placebo administered by emergency medical services.
The primary endpoint of CELEBRATE is a ranked 7-point scale of clinical outcomes at 30 days that include all-cause mortality, stroke, recurrent MI, acute stent thrombosis, new-onset heart failure (HF) or rehospitalization for HF, high-sensitivity cTnT levels ≥ 10 times ULN at 24 hours after PCI/angiography, or none of the preceding. The primary safety outcome is the incidence of severe or life-threatening bleeding based on GUSTO criteria at 30 days.
The trial, which was led by Arnoud Van ‘t Hof, MD PhD (Maastricht University Medical Center, the Netherlands), is slated for presentation as a late-breaking clinical trial at the American Heart Association 2025 Scientific Sessions in November in New Orleans, LA.