Coherus BioSciences Announces Positive Topline 24-Week Treatment Phase Three Results for CHS-1420 (HUMIRA® Biosimilar Candi...
January 10 2017 - 8:45AM
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.
Forward-Looking StatementsExcept 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:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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