Coherus BioSciences recently reported that its ongoing Phase 3 pharmacokinetic and bioequivalence study comparing biosimilar CHS-1420, a candidate treatment for plaque psoriasis, to Humira (adalimumab) successfully met its 12-week endpoints.
Specifically, the study demonstrated similarity between the two compounds as measured by the percentage of patients achieving 75% improvement in the extent of psoriasis and its severity (an index called PASI-75). CHS-1420, an adalimumab biosimilar, and Humira also demonstrated a similar safety profile and both drugs were well-tolerated.
“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, MD, chief medical officer of Coherus, in a recent press release. “These results confirm that CHS-1420 has a similar efficacy and safety profile to that of Humira, as no clinically meaningful differences were observed.”
The double-blind and parallel-group, confirmatory three-part clinical trial (NCT02489227) is being conducted in patients with active, moderate to severe, chronic plaque psoriasis. In its second part, patients randomly assigned to receive Humira will move to CHS-1420 treatment, modeling a chronic patient’s transition to a biosimilar. Coherus expects that full data from this second treatment period will be available by year’s end and plans to present it at an upcoming scientific conference. It also plans to file a Biologics License Application for CHS-1420 with the U.S. Food and Drug Administration based on findings from this second trial phase.
“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 … [put] us in excellent position to launch CHS-1420 in 2018.”
Psoriasis is an inherited systemic inflammatory disease of immune dysfunction, whose most obvious clinical feature is plaque of elevated, inflamed skin. Plaques are scaly, red, bumpy areas that are often itchy. They characteristically are found on the scalp, elbows, and knees. Plaque psoriasis is relatively common, affecting about 2%–3% of the U.S. population.