An investigational agent being developed to treat patients who have suffered a heart attack or heart-related chest pain, CS-747, an antiplatelet agent developed by Eli Lilly and Sankyo Company, was comparable to the current market leader, clopidogrel (Plavix), with regard to the safety endpoint studied, according to results of a Phase 2 study presented at the European Society of Cardiology (ESC) in Munich, Germany.
According to a release, the study, Joint Utilization of Medications to Block Platelets Optimally (JUMBO) - TIMI 26, while designed to examine safety, reported a non-statistically significant trend with the use of CS-747 when compared to clopidogrel in a reduction of additional heart-related problems, such as patients having another heart attack during the 30-day period in which they were observed.
The primary objective of the JUMBO study was to evaluate the safety of CS-747. The study was designed to compare the incidents of clinically significant bleeding events with CS-747 to those of clopidogrel in patients who had a procedure to open a blocked coronary artery with a stent. The researchers also examined whether there were fewer heart attacks, strokes and other heart problems after treatment with CS-747, the release says.
The study was conducted in conjunction with the TIMI Study Group at Harvard Medical School and Brigham and Women's Hospital in Boston, Mass. The group was headed by Eugene Braunwald, investigators in the trial from TIMI include Elliott Antman and Stephen Wiviott. The TIMI group conducts studies on different treatment regimens for patients with heart attacks, unstable angina and other cardiovascular diseases.
Six hundred fifty patients were assigned to the three CS-747 groups to test different doses of the compound, while 254 patients were assigned to the clopidogrel group. Patients were followed for 30 days for bleeding complications and "major adverse cardiovascular events (MACE)," such as death, heart attacks and stroke, the release added.
"We are encouraged by the results of the JUMBO - TIMI 26 trial, and we look forward to the Phase 3 trial in which we will compare CS-747 with clopidogrel on clinical events," said Dr. Braunwald, chairman of the TIMI Study Group.
"The JUMBO trial is the first study to report on the use of CS-747 in patients who are having a procedure to open a blocked artery. We are pleased with the outcome of this trial and look forward to the continued development of this agent for the treatment of patients with heart disease," said Holger Schilske, executive director, cardiovascular therapeutic area at Lilly.
"The JUMBO trial has met all of our expectations and has set the foundation for our Phase 3 program," said Tomás S Bocanegra, US vice president of clinical development at Sankyo. "We look forward to continuing to work with Lilly on the development of this important new treatment for patients with coronary disease," he added.
CS-747 is an oral antiplatelet agent that prevents platelet activation by blocking adenosine diphosphate receptors on the platelet surface. The novel oral compound was discovered by Sankyo and Ube industries, Ltd. (TSE:4208). It is being investigated for the treatment of patients with acute coronary syndrome who undergo percutaneous coronary intervention.