Coherus BioSciences, Inc. reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira®) biosimilar candidate. This study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12.
The 95% confidence intervals for the difference between treatment groups fell well within the prespecified margin. Both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in this study.
“We are pleased that this study met the 12-week primary equivalence endpoint for PASI-75 and are very confident that the 24-week results will be similar to that observed at Week 12,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “These results confirm that CHS-1420 has a similar efficacy and safety profile to that of Humira, as no clinically meaningful differences were observed.”
This was a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis. In treatment period 2, half the subjects randomized to Humira will cross-over to CHS-1420, modeling a chronic patient’s transition to a biosimilar.
Comparative safety, including immunogenicity, and durability of response to CHS-1420 and Humira at week 16 and 24 are key secondary endpoints. These data will be presented at an upcoming scientific conference. The full dataset through treatment period 2 will be available in Q4 2016 and included in the BLA submission to follow.
“Coming after four other successful Phase 3/BLA-enabling studies this year with two other programs, this positive Phase 3 result further validates the scientific, clinical and technical capabilities of Coherus BioSciences as a world-class biosimilar company,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
“We believe such capabilities taken together with our strong intellectual property focus and continued positive developments with patents and IPRs puts us in excellent position to launch CHS-1420 in 2018.”
