Glaxo Returns IBD Drugs Rights to ChemoCentryx
ChemoCentryx to Regain Global Rights for Vercirnon From GlaxoSmithKline
MOUNTAIN VIEW, Calif., Sept. 18, 2013 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq:CCXI) announced that GlaxoSmithKline (GSK) has returned to ChemoCentryx all rights to vercirnon (also known as Traficet-EN and CCX282), an inhibitor of the chemokine receptor known as CCR9, for all indications, including the treatment of inflammatory bowel disease.
"We are pleased to have a response from GSK which gives us certainty that vercirnon now returns entirely to ChemoCentryx, and which confers to us many degrees of freedom in deciding this valuable asset's forward path," stated Thomas J. Schall, PhD, President and Chief Executive Officer ChemoCentryx. "Importantly, in addition to regaining rights to the compound, the full data set amassed on all the trials (whether concluded or not) will be transferred to ChemoCentryx. Such data will allow us to assess, alone or potentially with a partner, a remaining, critical clinical trial question: that is, whether the drug maintains remission in Crohn's disease, as we saw in the maintenance phase of the previously conducted PROTECT-1 trial."
In August 2006, ChemoCentryx and GSK entered into a worldwide strategic alliance of which vercirnon was a part. Two other development programs remain under the alliance: CCX354, an inhibitor of the chemokine receptor known as CCR1 for the treatment of rheumatoid arthritis for which GSK exercised its option for an exclusive license in 2011 and CCX168, an inhibitor of the complement receptor C5a, currently in Phase II development for ANCA vasculitis.
About SHIELD-1 and PROTECT-1 Studies
The Phase III SHIELD-1 trial, conducted by GSK, was 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 in the induction of clinical response, compared to placebo (i.e., standard background medications) 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 patients who did not respond to tumor necrosis factor-alpha (TNF-α) antagonists.
The Phase II PROTECT-1 trial, conducted by ChemoCentryx, was a double-blind, randomized and placebo-controlled study that evaluated the efficacy and safety of two doses (250 mg and 500 mg) of vercirnon, compared to placebo in 436 patients, in induction and maintenance phases.
Notable differences in the SHIELD-1 trial design compared to that of PROTECT-1 included: (1) a patient population that was less ill in SHIELD-1 vs PROTECT-1, as measured by a lower Crohn's Disease Activity Index (CDAI) at entry (CDAI entry score of 220 in SHIELD-1 vs 250 in PROTECT-1) and (2) the introduction of a new dose in SHIELD-1, 500 mg twice daily, with which there was no prior clinical experience in Crohn's disease. The SHIELD-1 trial did not specifically address maintenance of remission in Crohn's disease.
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 or CCX282), is a Phase III-ready specific CCR9 inhibitor, for the treatment of inflammatory bowel disease. 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 the Company's ability to obtain assistance from third parties for the further funding and development of vercirnon and the progress of the Company's other development programs. 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.
CCXI — G
Source: ChemoCentryx, Inc.
Susan M. Kanaya
Senior Vice President, Finance and
Chief Financial Officer or
Markus J. Cappel, Ph.D.
Chief Business Officer
Kinkead Communications, Inc.
Posted: September 2013