Momenta and Mylan’s Biosimilar Candidate M834 Misses Initial Trial Goals

Momenta and Mylan’s Biosimilar Candidate M834 Misses Initial Trial Goals

Momenta Pharmaceuticals and Mylan recently reported that M834, a biosimilar candidate for abatacept designed to treat autoimmune diseases, did not meet its primary pharmacokinetic (PK) goals in a direct comparison study with Orencia (abatacept).

PK reflects the bodily absorption, distribution, metabolism, and excretion of a drug, the first steps in evaluating a new investigational therapy.

M834 is being developed as a biosimilar of Bristol-Myers Squibb’s Orencia. A biosimilar is a biologic drug with the same design and equivalent activity as an original patented biologic compound. Orencia is approved in the U.S. for the treatment of rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis.

Orencia is based on a fusion protein encompassing CTLA4 (cytotoxic T-lymphocyte-associated protein 4), which is a known checkpoint inhibitor that is able to downregulate immune responses. The drug acts as an “off” switch when bound to the surface of white blood cells that stimulate an immune response. M834 is a biologic consisting of protein components similar to Orencia and is designed to be equally effective in suppressing autoimmune reactions.

The Phase 1 clinical trial (NCT02923583) compared the pharmacokinetics of Momenta and Mylan’s M834 to those of Orencia in 243 normal, healthy volunteers. Safety and potential to induce an immune response (immunogenicity) of the two drugs were also evaluated.

Participants were divided into three groups who were injected subcutaneously with a single dose of either M834, EU-sourced Orencia, or U.S.-sourced Orencia for the purpose of comparison.

“This was an unexpected result and we are disappointed with the outcome of this PK study,” Craig Wheeler, president and chief executive officer of Momenta Pharmaceuticals, said in a press release.

“We are in the process of gathering the full data set and will work with Mylan to fully analyze these data to better understand the study results and evaluate next steps for this program. We remain committed to executing on our biosimilar portfolio,” Wheeler added.

M834 is a part of a collaboration between Momenta and Mylan. Orencia is the only CTLA-4Ig approved in the U.S. and EU for the treatment of juvenile idiopathic arthritis. Worldwide sales of Orencia totaled $2.4 billion in 2016.

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