REDWOOD CITY, Calif., July 16, 2014 /PRNewswire/ — Coherus BioSciences, Inc. announced the start of its Phase 3 trial of CHS-0214, a proposed biosimilar of etanercept (Enbrel®), in chronic plaque psoriasis (the RaPsOdy trial). This announcement follows the recent initiation of a Phase 3 trial of CHS-0214 in rheumatoid arthritis. The Phase 3 psoriasis trial is a 48-week, randomized, double-blind, active-control, parallel-group, multicenter, global study in subjects with active, chronic plaque psoriasis who are naïve to systemic biologic therapy. The study will seek to demonstrate biosimilarity between CHS-0214 and Enbrel® in terms of efficacy, safety and immunogenicity. The primary efficacy endpoint is based on percent improvement in the Psoriasis Area and Severity Index (PASI) at 12 weeks.
"The initiation of the Phase 3 RaPsOdy trial is an important step toward our goal of increasing access to biosimilar etanercept for patients worldwide," said Barbara Finck, M.D., Chief Medical Officer of Coherus. "It represents a pivotal study in the global clinical development for CHS-0214 and, if positive, will provide support for our marketing applications in Europe, the United States, and a number of other countries."
"Based on our evaluation of the analytical, nonclinical and clinical pharmacokinetic similarity of this molecule, we believe that this molecule has met our rigorous internal criteria for initiating our second Phase 3 trial in 2014," said Denny Lanfear, Coherus Chief Executive Officer. "In concert with our partner Baxter, we are pleased to advance this product into late-stage development."
"With two late-stage trials now underway in partnership with Coherus, we are advancing our collective goals to develop and deliver high quality biologic alternatives that address patient needs," said Ludwig Hantson, Ph.D., president of Baxter BioScience.