One of GlaxoSmithKline's ($GSK) late-stage assets for Crohn's disease has failed a Phase III study, pushing the pharma giant to suspend patient recruitment in the ambitious program. The pharma giant says vercirnon, an inhibitor of the chemokine receptor known as CCR9 in-licensed from ChemoCentryx ($CCXI), flunked the first of four Phase III trials.
The drug failed the primary endpoint of improvement in clinical response as well as the key secondary endpoint of clinical remission when compared to a placebo arm. ChemoCentryx CEO Thomas Schall quickly moved to try and calm investors by switching focus to the other drug's in the biotech's pipeline.
ChemoCentryx's stock plunged 47% Friday morning on the news.
"New recruitment and dosing in the ongoing clinical program has been suspended pending further review of the SHIELD-1 results," reports ChemoCentryx.
GSK had a big program under way. This first trial recruited 608 patients and tested two 500 mg doses--once and twice daily--for moderate to severe Crohn's. The primary endpoint focused on a score of at least 100 points at 12 weeks on the Crohn's Disease Activity Index. Clinical remission (CDAI score less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.
Glaxo bought into the drug back in 2006, when it inked a $1.5 billion deal--$63.5 million upfront--with ChemoCentryx to explore new drugs for inflammatory bowel disease. At that time vercirnon, or Traficet-EN, was in Phase II/III studies.
"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," said Schall in a statement. "Other CCXI pipeline programs are moving along per plan, unaffected by the SHIELD program. For example, in our wholly-owned lead program, the CCR2 inhibitor CCX140, we look forward to the 12-week interim analysis from the ongoing 52-week Phase II study in diabetic nephropathy later this quarter. Also, we anticipate additional clinical data and an option decision in the fourth quarter of this year by GSK on CCX168, our C5aR inhibitor, which is currently in Phase II clinical development for the treatment of renal vasculitis."
- here's the press release