GSK Crohn's Disease Drug Fails Trial, Licensor ChemoCentryx Stock Tanks

(RTTNews) - GlaxoSmithKline plc (GSK.L, GSK) said Friday that a phase 3 trial of vercirnon to treat Crohn's disease failed to meet the primary endpoint of improvement in clinical response compared with placebo.

Following the announcement, shares of ChemoCentryx Inc. (CCXI), which has licensed vercirnon to GlaxoSmithKline, tumbled 31.6 percent or $3.69 at $7.99 on the Nasdaq.

GlaxoSmithKline's phase 3 study, dubbed SHIELD-1, is one among four late-stage studies assessing the efficacy of vercirnon to treat Crohn's disease - a chronic inflammatory condition of the digestive tract.

Elaborating on the SHIELD-1 study, GlaxoSmithKline said the rates of serious adverse events and withdrawals due to such events were similar among all treatment groups including placebo.

GlaxoSmithKline indicated plans to continue exploring the safety and efficacy results to inform decisions on the clinical development program for vercirnon. New recruitment and dosing in the ongoing program has been suspended pending further review of the SHIELD-1 results.

"While we are clearly very disappointed with the results from the GSK SHIELD-1 study, we await GSK's decision on the future development plan for the vercirnon program following their further analysis of their data," stated Thomas Schall, chief executive officer of ChemoCentryx.

SHIELD-1 is a randomized, double-blind, placebo-controlled trial that assessed the efficacy and safety of two doses of vercirnon compared to placebo over 12 weeks in 608 adult patients with Crohn's disease.

Vercirnon is an investigational non-biologic, orally administered CCR9 antagonist which GSK licensed from ChemoCentryx in January 2010.

Crohn's disease is estimated to affect over 600,000 patients in North America and about 830,000 in Europe.

Shares of ChemoCentryx are trading at $7.99, down $3.69 or 31.61%, on a volume of 3.3 million shares on the Nasdaq.

GlaxoSmithKline stock is trading at $52.00, down $0.05 or 0.10%, on a volume of 0.9 million shares on the NYSE. In London, the stock closed at 1,673.00 pence, up 17.50 pence or 1.06%, on a volume of 3.8 million shares.