Abandoned by GlaxoSmithKline, ChemoCentryx will try again on troubled Crohn's drug

This morning ChemoCentryx ($CCXI) reported that GlaxoSmithKline ($GSK) has returned all rights to the Crohn's drug vercirnon, a day after the pharma giant confirmed to FierceBiotech that it had shuttered the three remaining late-stage studies it had mounted for the program. And while the Mountain View, CA-based biotech put the best spin on the news it could, touting the potential for finding a new partner and mounting a new trial, it's likely to experience some major headwinds after GlaxoSmithKline highlighted serious side effects seen at the high doses of the drug as well as a clear lack of efficacy.

In a Sept. 12 update on the clinical trial registry Clinicaltrials.gov, the slate of Phase III studies dubbed SHIELD 1, 2 and 3 were all listed as terminated, though the biotech did not disclose that at the time. The last official word from ChemoCentryx came on the news a few weeks ago that the first Phase III study had failed, noting that GlaxoSmithKline was still reviewing the data before deciding how to proceed.

"No efficacy was observed with either dose of vercirnon over 12 weeks in SHIELD-1," noted a GlaxoSmithKline spokesperson yesterday. In addition, dose-dependent increases in rates of adverse events (AEs), gastrointestinal AEs, and cardiac AEs, including two cardiac serious AEs in the 500 mg twice daily group, were observed. Those findings have reduced the benefit to risk profile of vercirnon and don't support the continued treatment of the study patients."

Glaxo inked a $1.5 billion deal--$63.5 million upfront--with ChemoCentryx back in 2006 to explore new drugs for inflammatory bowel disease.

ChemoCentryx CEO Thomas Schall, though, said he was pleased today.

"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 Schall in a statement. "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."

- here's the press release

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