Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in 243 normal healthy volunteers.
The Phase I study was a randomized, double-blind, three-arm, parallel group, single-dose subcutaneous administration clinical study to compare M834 with ORENCIA, a fusion protein targeting CTLA-4 to treat autoimmune diseases, such as rheumatoid arthritis, by interfering with the immune activity of T cells.