MSD insulin glargine biosimilar meets primary endpoint in late-stage trials
MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating its insulin glargine biosimilar candidate, MK-1293.
In both trials, the biosimilar achieved its primary endpoint by demonstrating non-inferiority in change from baseline average blood glucose measure A1c, as well as similar safety to Lantus (insulin glargine) after 24 weeks in patients with type-1 and type-2 diabetes. Furthermore, the biosimilar also demonstrated statistical A1c equivalence to Lantus in these trials, showing that its similarity is within an acceptable range.
The development of this drug builds on a 2013 agreement between MSD and Samsung Bioepis to develop and commercialise multiple biosimilar candidates across different therapeutic areas. Under the terms of a subsequent 2014 agreement, MSD will handle clinical development, manufacturing and, if approved, commercialisation of MK-1293. Samsung Bioepis continues to partially fund its development.
Peter Stein, VP of late stage development in diabetes at MSD, says: “The investigational agent MK-1293 represents [MSD’s] entry into insulin therapeutics and into treatments that may be useful for patients with type-1 diabetes, and we are pleased with these Phase III results. As a follow-on biologic, MK-1293 has the potential to offer a treatment option for paediatric and adult patients with type-1 diabetes and for adults with type-2 diabetes who use basal insulin to help control their glucose levels.”
The results were presented at the 76th Scientific Sessions of the American Diabetes Association.
Merck (known as MSD outside of the US and Canada) and Caraway Therapeutics have announced …
Merck, known as MSD outside of the US, has announced that the US Food and …