Data presented as Late Breaking Trial at EuroPCR and published in Eurointervention show a single subcutaneous injection of RUC-4 consistently induced high-grade inhibition of platelet function
SAN DIEGO, May 18, 2021 – CeleCor Therapeutics, Inc. today announced the presentation of clinical trial results of RUC-4 in in patients experiencing a ST-segment Elevation Myocardial Infarction (STEMI). The data was presented in a Late Breaking Trial and published simultaneously in Eurointervention. The open-label, dose-escalating phase 2A clinical study (CEL-02) in 27 patients with ST-segment elevation myocardial infarction (STEMI) demonstrated a single subcutaneous dose of 0.110 mg/kg of zalunfiban (RUC-4), a second-generation glycoprotein IIb/IIIa inhibitor (GPI), consistently induced high-grade inhibition of platelet function within 15 minutes, with 50% of return of function at a median of 112 minutes. The study also did not observe thrombocytopenia with zalunfiban treatment. Different from current GPIs, zalunfiban locks the GPIIb/IIIa receptor in its inactive state and does not induce a major conformational change implicated in the development of thrombocytopenia. The company is currently conducting a pivotal clinical trial, called CELEBRATE, in more than 1,600 STEMI patients treated in ambulances.
“This clinical study in STEMI patients showed that zalunfiban (RUC-4) rapidly achieved dose-dependent high grade inhibition of platelet function, consistently reaching a level of inhibition of platelet function at the highest dose that has been shown to correlate with improved clinical outcomes in patients treated with other GPIs,” said Jurrien ten Berg, M.D., Ph.D., M.Sc., FESC, FACC, Director of the Cardiology Training Program and Head of the St. Antonius Center for Platelet Function Studies at the St Antonius Hospital, the Netherlands, and principal investigator of the CEL-02 clinical study. “While early treatment with first generation GPIs improves outcomes, these approved drugs are limited in use for prehospital treatment because they require IV administration as a bolus followed by continuous infusion.”
Zalunfiban (RUC-4), a next generation GPI, is specifically designed to be administered subcutaneously to inhibit platelet aggregation for a first-point-of-medical contact treatment to improve outcomes for STEMI patients. Inhibiting platelet aggregation can slow or stop blood clot formation leading to coronary artery blockage, and in turn, can stop or prevent a heart attack. Zalunfiban targets platelet GPIIb/IIIa receptors, the final common pathway in platelet aggregation, to inhibit all platelet activators and can, under some conditions, promote recanalization of occluded arteries. In contrast, other antiplatelet medications, including P2Y12 inhibitors and aspirin, inhibit only one platelet activator and have not been demonstrated to promote recanalization. Further, due to decreased gastrointestinal absorption, oral P2Y12 inhibitors given before the procedure to open the artery do not act rapidly or reliably enough in STEMI patients during the crucial early minutes of a heart attack and have not demonstrated a clinical benefit to date.
Arnoud van’t Hof, M.D., Ph.D., FESC, Head of the Department of Interventional Cardiology, Maastricht University Medical Center, the Netherlands, and principal investigator of the CELEBRATE study, said, “This study continues to build on the data supporting the potential of zalunfiban as a first point-of-contact STEMI therapy to fulfill a significant unmet medical need in the pre-hospital phase of heart attack care. We are enrolling in the CELEBRATE trial, and we believe this study will provide important clinical data to support the use of zalunfiban in the pre-hospital treatment of STEMI patients.”
The Phase 2b CELEBRATE trial, currently underway, is a double-blinded, randomized, placebo-controlled study that will take place at international multidisciplinary coronary care centers and will evaluate more than 1,600 STEMI patients treated with zalunfiban or placebo while en route to the hospital in an ambulance. The trial will assess the effect of patients receiving one of two different doses of zalunfiban versus placebo on restoration of coronary artery blood flow before percutaneous coronary intervention (PCI) and resolution of ST-segment deviation post PCI.
About CeleCor Therapeutics
CeleCor Therapeutics, Inc. is a biotechnology company focused on developing a first-point-of-contact therapy to improve the treatment of serious heart attacks, specifically ST-segment Elevation Myocardial Infarction (STEMI). The company’s lead clinical-stage candidate is zalunfiban, a novel small molecule inhibitor of the platelet GPIIb/IIIa (αIIbβ3) receptor, designed to be easily administered subcutaneously. CeleCor is headquartered in San Diego. For more information, visit www.celecor.com.
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