CeleCor Therapeutics announced that its multinational Phase 3 CeleBrate trial of the investigational heart-attack drug Disaggpro™ (zalunfiban) has met its primary efficacy and primary safety outcomes.
Full study results will be presented on November 10 during the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans.
The Urgent Need for Pre-Hospital Treatment
- At least 50% of heart-attack deaths occur before patients reach the hospital.
- In-hospital treatments for heart attacks have advanced significantly.
- Yet, in the U.S., aspirin remains the only routinely used antiplatelet therapy before hospital arrival.
Disaggpro was developed to fill this critical gap, enabling treatment in pre-hospital settings for patients experiencing ST-segment elevation myocardial infarction (STEMI)—the most severe type of heart attack.
Why It Matters
- STEMI heart attacks account for ~40% of heart-attack cases.
- In STEMI, a blood clot almost always blocks blood flow to part of the heart.
- The key to survival is restoring blood flow as quickly as possible to prevent death or irreversible heart damage.
About Disaggpro™ (Zalunfiban)
- Drug class: Next-generation investigational GPIIb/IIIa inhibitor.
- Formulation: Subcutaneous injection via auto-injector.
- Volume: Full therapeutic dose in <1 mL (less than ¼ teaspoon).
- Onset: Maximal effect within 15 minutes.
- Pharmacokinetics: Half-life of ~1 hour.
This design makes Disaggpro suitable for rapid administration outside the hospital.
The CeleBrate Study
- Design: Pivotal Phase 3, prospective, double-blinded, randomized, placebo-controlled.
- Intervention: Single subcutaneous injection of Disaggpro in STEMI patients before hospital arrival.
- Enrollment: 2,467 patients.
- Sites: 45 locations across the United States, Canada, Mexico, and Europe.
