ChemoCentryx, Inc., a clinical-stage biopharmaceutical company, has regained all rights for vercirnon (also known as Traficet-EN and CCX282) from GlaxoSmithKline (GSK). Vercirnon is 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.
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 tumour necrosis factor-alpha (TNF-a) 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: 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 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 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.