GlaxoSmithKline (GSK) has returned all rights to vercirnon to ChemoCentryx for all indications including inflammatory bowel disease, for which the drug candidate was studied in a Phase III trial. According to a report issued last month, the trial had disappointing results.
The return of rights, disclosed today by ChemoCentryx, ends one piece of a seven-year, worldwide strategic alliance between the companies. The alliance began in 2006, when GSK paid ChemoCentryx $63.5 million up front, with the potential for additional payments of up to $1.5 billion, to study possible treatments for inflammatory bowel disease. Among them was vercirnon, then a Phase II/III drug candidate, which GSK licensed from ChemCentryx in 2010.
Last month, GSK said that vercirnon, a CCR9 antagonist also known as Traficet-EN and CCX282, failed to meet its primary endpoint (improvement in clinical response) and the key secondary endpoint (clinical remission) in the first of four planned Phase III trials, called SHIELD-1.
In SHIELD-1, conducted by GSK, two doses of vercirnon (500 mg once daily and 500 mg twice daily) were compared to placebo over 12 weeks in 608 adults with moderately to severely active Crohn’s disease. Patients were deemed not adequately controlled with conventional therapy, or did not respond to tumor necrosis factor-alpha antagonists.
“The results from the SHIELD-1 study are clearly disappointing, but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease,” Paul-Peter Tak, M.D., Ph.D., svp of immunoinflammation research and development at GSK, said in a statement at the time.
GSK also said back then that full results from SHIELD-1 “will be submitted to a forthcoming scientific congress and peer-reviewed scientific journal.”
In today’s announcement by ChemoCentryx, Thomas J. Schall, Ph.D., the company’s president and CEO, said that GSK’s return of rights “confers to us many degrees of freedom in deciding this valuable asset's forward path."
“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,” Dr. Schall said. “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."
PROTECT-1 was a Phase II trial conducted by ChemoCentryx, in which vercirnon doses of 250 mg and 500 mg were studied for safety and efficacy compared to placebo in 436 patients with moderately to severely active Crohn's disease. The trial included induction and maintenance phases.
ChemoCentryx said its alliance with GSK will continue two other development programs. The first is CCX354, a CCR1 inhibitor for rheumatoid arthritis for which GSK exercised its option for an exclusive license in 2011. The second is CCX168, an inhibitor of the complement receptor C5a, currently in Phase II development for ANCA vasculitis.