Merck's Insulin Glargine, MK-1293, Met Primary Endpoint In Two Phase 3 Studies

(RTTNews) - Merck & Co Inc. (MRK) announced results from two Phase 3 studies evaluating MK-1293, Merck's investigational, follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes.

In both studies, MK-1293 achieved its primary endpoint by demonstrating non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus (insulin glargine) after 24 weeks in patients with type 1 and type 2 diabetes.

In addition, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy.

MK-1293 has the same amino acid sequence as Lantus, the originator insulin glargine. The development of MK-1293 builds on an agreement between Merck and Samsung Bioepis established in February 2013 to develop and commercialize multiple biosimilar candidates across different therapeutic areas. Under the terms of a subsequent 2014 agreement, Merck is responsible for the clinical development, manufacturing and, if approved, commercialization of MK-1293. Samsung Bioepis is partially funding its development.