GSK Crohn's disease Trial Misses Primary Endpoint
ChemoCentryx Announces GlaxoSmithKline's Release of Top-Line Results From the SHIELD-1 Phase III Study of Vercirnon
MOUNTAIN VIEW, Calif., Aug. 23, 2013 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq:CCXI) reports that GlaxoSmithKline (GSK) announced today that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon, an inhibitor of the chemokine receptor known as CCR9, in patients with moderate-to-severe Crohn's disease did not achieve the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission. The rates of serious adverse events and withdrawals due to adverse events were similar among all treatment groups including the placebo group, with a trend in dose-dependent increases in overall adverse event rates. GSK has indicated that it intends to continue to explore the safety and efficacy results to inform decisions about the clinical development program for vercirnon. New recruitment and dosing in the ongoing clinical program has been suspended pending further review of the SHIELD-1 results.
"While we are clearly very disappointed with the results from the GSK SHIELD-1 study, we await GSK's decision on the future development plan for the vercirnon program following their further analysis of their data," stated Thomas J. Schall, PhD, President and Chief Executive Officer ChemoCentryx. "Other CCXI pipeline programs are moving along per plan, unaffected by the SHIELD program. For example, in our wholly-owned lead program, the CCR2 inhibitor CCX140, we look forward to the 12-week interim analysis from the ongoing 52-week Phase II study in diabetic nephropathy later this quarter. Also, we anticipate additional clinical data and an option decision in the fourth quarter of this year by GSK on CCX168, our C5aR inhibitor, which is currently in Phase II clinical development for the treatment of renal vasculitis."
About SHIELD-1 Study
SHIELD-1 is a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of vercirnon compared to placebo over 12 weeks in 608 adult patients with moderate-to-severe active Crohn's disease.
The study was conducted in patients who were not adequately controlled with conventional therapy, and included patients who did not respond to tumor necrosis factor-alpha (TNF-alpha) antagonists.
The primary endpoint was the proportion of patients achieving clinical response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points at 12 weeks. Clinical remission (CDAI score less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.
The study was conducted at over 200 study centers globally.
About Vercirnon (GSK1605786)
Vercirnon is an investigational non-biologic, orally administered CCR9 antagonist which GSK licensed from ChemoCentryx in January 2010.
About Phase III Clinical Program
The Phase III clinical development program for vercirnon comprises four studies (SHIELD-1, SHIELD-2, SHIELD-3 and SHIELD-4) designed to evaluate the efficacy and safety of vercirnon for inducing a clinical response and remission (reduction or disappearance of symptoms) and maintaining remission in over 2,500 patients with moderately-to-severely active Crohn's disease.
About Crohn's disease
Crohn's disease is a chronic inflammatory condition of the digestive tract. It most commonly affects the lower part of the gastrointestinal tract, causing symptoms such as persistent diarrhea, abdominal pain, fever, rectal bleeding, loss of appetite and weight loss. It is estimated that the disease affects over 600,000 patients in North America and approximately 830,000 in Europe. Patients suffer periods of flare-ups characterized by intense symptoms, interspersed with periods of relative remission where symptoms decrease or disappear. Current treatment options include corticosteroids, immunomodulators or biologics. Following diagnosis, patients frequently need to continue therapy lifelong, often layering additional therapies as flare-ups recur or persist. There is currently no curative medical therapy and many patients progress to surgery when treatments no longer control the symptoms.
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds.
Vercirnon (also known as Traficet-EN, CCX282 or GSK1605786), a specific
CCR9 inhibitor, is now being solely developed by GSK and is currently in Phase III clinical development. The Company's lead independent drug candidate, CCX140, a CCR2 inhibitor, has been shown to be safe and well tolerated while demonstrating clinical activity on glycemic indices in a Phase II clinical trial in type 2 diabetics, and is now in Phase II clinical development for the treatment of diabetic nephropathy. Other clinical programs include CCX354 (also known as GSK2941266), a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis, CCX168, a C5aR inhibitor in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, as well as CCX872, a
CCR2 inhibitor, and CCX507, an inhibitor of CCR9, both of which are in Phase I clinical testing. ChemoCentryx also has several programs in advanced preclinical development.
ChemoCentryx cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will,""would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential" or "continue" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations and include the Company's statements regarding its expectations as to GSK's intentions with respect to the further development of vercirnon, the progress of the Company's other development programs, and when GSK will report data or make its option decision. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K for the year ended December 31, 2012 which is available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.ChemoCentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
All inquiries regarding the SHIELD-1 study should be directed to the GSK contacts listed on the GSK press release.
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Source: ChemoCentryx, Inc.
CONTACT: Susan M. Kanaya
Senior Vice President, Finance and
Chief Financial Officer or
Markus J. Cappel, Ph.D.
Chief Business Officer
Posted: August 2013