Trial of losmapimod for treatment of ACS will not go forward as designed

GlaxoSmithKline announced that it will not proceed with the next stage of the LATITUDE-TIMI 60 study of losmapimod as currently designed.

According to a press release from the company, an interim review of data from the first part of the phase 3 study of 3,503 patients with ACS “did not indicate efficacy against the primary endpoint and did not support investment in the larger part B of the study as currently designed.” Patients in the first part of the double blind, multicenter trial were randomly assigned to receive either placebo or 7.5 mg losmapimod twice a day for 3 months, in addition to standard care. The primary endpoint was major adverse CV events, defined as CV death and time to first occurrence of MI or severe recurrent ischemia that required urgent coronary artery revascularization, according to the release.

The company stated in the release that there was an efficacy signal associated with losmapimod, an inhibitor of p38, a mitogen-activated protein kinase, in a subgroup of 866 patients with STEMI. Though not statistically significant due to a small number of events, researchers observed reductions of 30% to 50% in the endpoints of CV death, HF-related hospitalization and a composite of the two in that population, according to the release.

The company stated that it will “assess these findings over the next few months to evaluate all options for future development,” and that full results from the first part of the study will be submitted for presentation at a future conference.