Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.
This randomized, double-blind, multicenter study evaluated the efficacy, safety and immunogenicity of M923 in adults with moderate-to-severe chronic plaque psoriasis. For 48 weeks patients received M923, adalimumab, or adalimumab alternating with M923.
The reduction in PASI-75 with M923 was deemed equivalent to adalimumab, with the estimated difference in responders falling well within the pre-specified confidence interval. The secondary endpoints; equivalence in PASI-50 and PASI-90 between M923 and adalimumab, was also achieved. Adverse events were comparable across treatment groups and consistent with previously published safety data for adalimumab.
“These positive data support the biosimilarity of M923, and further advance us toward our goal of gaining regulatory approval for this important program,” said Craig A. Wheeler, President and CEO of Momenta Pharmaceuticals.
For more information visit Momentapharma.com.