Investigational Enbrel biosimilar CHS-0214 meets primary endpoints
Posted: 10 November 2015 |
CHS-0214 met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis…
Coherus BioSciences and Baxalta have announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis.
“We are pleased with this positive clinical outcome,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “CHS-0214 is an important option for patients requiring treatment with etanercept. If approved by regulatory agencies, CHS-0214 has the potential to offer patients a high-quality treatment option for conditions for which etanercept is indicated.”
“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
No clinically meaningful differences in the safety profiles of CHS-0214 and Enbrel
The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety profiles of the products.
“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars, Baxalta. “Plaque psoriasis has a significant impact on a patient’s quality of life and self-perception, so early access to treatment is imperative. If approved, CHS-0214 would expand access of treatment options for patients with moderate-to-severe chronic plaque psoriasis.”
The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.