ChemoCentryx Reports Positive PROTECT-1 Study Results For Traficet-EN(TM) At The GASTRO 2009 UEGW/WCOG Conference

Main Category: Crohn's / IBD
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 26 Nov 2009 - 2:00 PDT

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ChemoCentryx, Inc., announced that Phase II/III clinical data from the Company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile. The study demonstrated evidence of clinical efficacy in the reduction of disease severity as defined as a 70-point decrease in the Crohn's Disease Activity Index (CDAI) in patients treated with Traficet-EN over the course of 12 weeks; the more stringent measure of at least a 100-point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment benefited patients who had previously not responded to anti-TNF treatment. These results reported from the Induction phase of the PROTECT-1 trial, were presented today in a poster titled "PROTECT-1 Study of Intestine-Specific Chemokine Receptor Antagonist CCX282-B (TRAFICET-EN) in Crohn's Disease" by Satish Keshav, M.D., Department of Gastroenterology, John Radcliffe Hospital, Oxford University at the GASTRO 2009 United European Gastroenterology Federation and World Gastroenterology Organization (UEGW/WCOG) conference in London.

Traficet-EN is an orally-active inhibitor of the chemokine receptor known as 'CCR9', which is selectively expressed by inflammatory T cells to migrate to the digestive tract in a process that ultimately results in the persistent inflammation underlying the disease. Targeting the CCR9 chemokine receptor represents a novel approach for the treatment of Crohn's disease and other inflammatory disorders of the gastrointestinal system.

Study Results

Results showed that the CDAI >/= 70-point response in patients with small bowel and/or colonic Crohn's disease treated with 500 mg once-daily dose (QD) of Traficet-EN for 12 weeks was 61% versus 47% for placebo (p=0.039). Similarly, the CDAI >/= 100-point response was 55% in patients treated with 500 mg QD of Traficet-EN as compared to 40% in the placebo group (p=0.029). C-reactive protein (CRP) results confirmed the effect of 500 mg QD Traficet-EN. Traficet-EN was well tolerated with a favorable side-effect profile.

"By blocking the CCR9 chemokine receptor, we believe that Traficet-EN has the potential to offer a dramatically new treatment paradigm with significantly fewer side effects than currently available therapies for Crohn's disease," said Pirow Bekker, M.D., Ph.D., Senior Vice President, Medical and Clinical Affairs of ChemoCentryx. "Additionally, an effective oral capsule given once daily would represent a significant improvement in patient convenience and compliance as compared to existing infusion or injection regimens - an important milestone considering the lifestyle disruption already experienced by these patients as a result of Crohn's debilitating effects."

"Targeting the CCR9 chemokine receptor is therapeutically unprecedented," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "These results solidify our leadership position in CCR9-based therapies and position Traficet-EN as a first-in-class anti-inflammatory agent for the treatment of Crohn's disease. More importantly, this study demonstrates that Traficet-EN has the potential to offer patients a novel, meaningful treatment option."

Study Design

The randomized, placebo-controlled, double-blind clinical trial of 436 patients is comprised of three discrete phases which allows for evaluation of efficacy and safety of Traficet-EN in inducing a clinical response or remission, as well as maintaining response/remission in Crohn's disease over a combined total of 12 months. The 12-week Induction phase of the study is followed by a 4-week, open-label phase, during which all subjects receive Traficet-EN. Patients who achieve a pre-specified 70-point or greater reduction in CDAI are re-randomized to active drug or placebo for an additional 36-week Maintenance phase, thereby permitting an evaluation of the drug's ability to maintain a treatment response. CDAI is a research tool used for determining a patient's level of disease activity and is the key measure regarded by regulatory agencies as an appropriate endpoint to assess the efficacy of a drug for the treatment of Crohn's disease.

About Traficet-EN(TM) (CCX282-B)

Traficet-EN is a small molecule, orally bioavailable drug that is administered in capsule form and which is believed to control the inappropriate immune system response underlying inflammatory bowel disease (IBD) by blocking the CCR9 chemokine receptor. In adults, CCR9 is a highly specific receptor expressed by T cells that migrate to the digestive tract. The trafficking of T cells to the small and large intestine causes persistent inflammation that may result in Crohn's disease or ulcerative colitis - the two principal forms of IBD. In preclinical studies, the compound worked both therapeutically and prophylactically in models of Crohn's disease and ulcerative colitis. ChemoCentryx has completed six Phase I clinical trials and one four-week Phase II Crohn's disease trial of Traficet-EN at doses up to 1000 mg twice daily, demonstrating that the product candidate is well-tolerated and appropriate for once-daily or twice-daily oral dosing. Traficet-EN may offer advantages over existing therapeutic approaches for Crohn's disease by potentially offering reduced side effects and convenient oral dosing to patients. Traficet-EN is being developed under a strategic alliance with GlaxoSmithKline's Center of Excellence for External Drug Discovery (CEEDD).

About Crohn's Disease

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract. It is estimated that the disease affects over 500,000 patients in Europe and North America. Patients suffer periods of flare-ups characterized by intense symptoms, interspersed with periods of relative remission where symptoms decrease or disappear. As Crohn's disease is a chronic condition, patients continue on therapy from the time of diagnosis over the course of a lifetime, layering additional therapies as flare-ups recur or persist in an effort to reduce symptoms. When medications can no longer control symptoms, patients have few options beyond surgery.

About ChemoCentryx

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 network of secreted chemokine molecules, or ligands, and cell surface receptors that regulates inflammation. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has internally generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. ChemoCentryx's lead compound, Traficet-EN, a specific CCR9 antagonist, completed a Phase II/III multi-national clinical trial, called PROTECT-1, in patients with moderate-to-severe Crohn's disease. CCX025, also a CCR9 antagonist, successfully concluded a Phase I clinical program. Additional clinical programs include the development of CCX140, which targets the CCR2 receptor, expected to enter Phase II clinical development in the first quarter of 2010 for the treatment of type 2 diabetes mellitus, and CCX354, a CCR1 antagonist expected to enter Phase II by year end for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in preclinical development. ChemoCentryx is privately held.

Any statements in this press release about ChemoCentryx's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as may, believe, will, expect, anticipate, estimate, intend, predict, seek, potential, continue, plan, should, could and would or the negative of these terms or other comparable terminology. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to (i) the initiation, timing, progress and results of ChemoCentryx's preclinical studies and clinical trials, (ii) ChemoCentryx's ability to advance product candidates into clinical trials, (iii) GSK's exercise of its license options, (iv) the commercialization of ChemoCentryx's product candidates, (v) the implementation of ChemoCentryx's business model, strategic plans for its business, product candidates and technology, (vi) ChemoCentryx's ability to maintain and establish collaborations or obtain additional government grant funding, (vii) ChemoCentryx's estimates of its expenses, future revenues, capital requirements and its needs for additional financing, (viii) the timing or likelihood of regulatory filings and approvals, (ix) the availability of corporate partners, (x) the scope of protection ChemoCentryx is able to establish and maintain for intellectual property rights covering its product candidates and technology, (xi) the impact of competitive products and technological changes, (xii) the availability of capital and the cost of capital, (xiii) ChemoCentryx's financial performance, (xiv) developments relating to ChemoCentryx's competitors and other vagaries in the biotechnology industry and (xv) other risks.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and ChemoCentryx undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Source: ChemoCentryx, Inc

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