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news.Cubist Pharmaceuticals, a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment, is planning to stop investing in the clinical development of CB-500,929 (ecallantide) as a therapy to reduce blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass.
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Cubist Pharma made this decision after reviewing top line efficacy and safety data from the CB-500,929 Phase 2 Conserv 1 and Conserv 2 trials. Cubist Pharma said that the decision would not impact the 2010 R & D cost guidance announced by it in January 2010 as the guidance did not include costs for potential development of CB-500,929 beyond the Conserv trials.
Reportedly, Conserv 1 study treated 249 patients undergoing primary Coronary Artery Bypass Graft (CABG) Surgery–while on cardiopulmonary bypass (CPB). The patient population was considered to be at a relatively low risk of bleeding complications in comparison to the Conserv 2 population. Three doses of CB-500,929 (approximately 5, 25 or 75 mg depending on a patient’s weight and time on bypass) were evaluated vs placebo.
The results for the trial showed no improvement in blood loss (measured by the need for transfusion of blood and blood products) vs placebo for any of the three doses studied. Conserv 1 results showed similar safety results in patients who received study drug and those who received placebo.
Additionally, in Conserv 2 study 218 patients were treated who were undergoing cardiac surgery while on CPB for procedures including repeat sternotomy, CABG + valve replacement or more than one valve replacement. This patient population was considered to be at a higher risk of bleeding complications than those undergoing a primary CABG procedure.
In Conserv 2, a dose of approximately 75mg of CB-500,929 was studied vs tranexamic acid as a comparator. The results of this trial also showed no treatment benefit for the CB-500,929 group relative to the comparator arm. A statistically significant higher rate of mortality was observed in patients in the study arm relative to those treated with tranexamic acid.
The imbalance in mortality was observed by the Data Safety Monitoring Board late last year, and led Cubist to end enrollment in the Conserv 2 trial early. At that time, the company had also decided to end enrollment early in Conserv 1 as a precaution although there was no imbalance in mortality observed in the Conserv 1 results.
Given the decision by Cubist to end its development of CB-500,929, Cubist plans to terminate the 2008 agreement with Dyax under which Cubist in-licensed development and commercialisation rights to CB-500,929 for surgical indications in the US and the EU in accordance with the terms of the agreement.