Coherus BioSciences, Inc. (NASDAQ:CHRS), today reported results from an ongoing 3-Part, Phase 3 clinical study of CHS-1420, an adalimumab (HUMIRA) biosimilar candidate. As previously reported, 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 …
Coherus BioSciences, Inc. (NASDAQ:CHRS), today reported results from an ongoing 3-Part, Phase 3 clinical study of CHS-1420, an adalimumab (HUMIRA) biosimilar candidate. As previously reported, 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 pre-specified margin.
Results from Part 2 of the study focused on maintenance of response through Week 24. At the start of Part 2 (Week 16), 80.3% of subjects in the CHS-1420 group and 77.5% of subjects in the HUMIRA group achieved PASI-75. In Part 2 (weeks 16-24), half of the subjects who were initially treated with HUMIRA were switched to CHS-1420, modeling a chronic patient’s transition to a biosimilar. In Part 2, maintenance of PASI-75 was similar across the 3 subsequent treatment groups: CHS-1420 followed by CHS-1420, HUMIRA followed by CHS-1420, and HUMIRA followed by HUMIRA. CHS-1420 and HUMIRA were similarly well tolerated in all groups during Part 2. Anti-drug antibody results are preliminary at this time, but have not identified any clinically significant differences between the treatment groups. This is a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis. In Part 3, all subjects receive CHS-1420 for an additional 24 weeks. Data from this study will be presented at an upcoming scientific conference. We currently anticipate filing the Biologic License Application (BLA) submission in the first half of 2017.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities, expectations, objectives, strategies, product pipeline, clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to submit a BLA in the first half of 2017. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the Securities and Exchange Commission on November 9, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.HUMIRA® is a registered trademark of AbbVie Inc.CONTACT:
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
+1 (650) 649-3527