Galapagos, which specialized in novel modes-of-action, and AbbVie have extended their GLPG0634 clinical development collaboration to include Crohn's disease. Galapagos will fund and complete a phase II program in Crohn's, designed to facilitate rapid progression into phase III. Upon successful completion of the study, expected in the second quarter of 2015, AbbVie will pay Galapagos $50 million.
AbbVie will be responsible for funding and performing clinical development beyond phase II and completing regulatory and commercialization activities.
Galapagos will start an innovative 20-week phase IIa/b study with GLPG0634 in 180 patients suffering from Crohn's by early 2014. The study will measure both induction of disease remission and early maintenance of its beneficial effects in Crohn's, and is expected to read out topline results. This phase II study will be performed in parallel with the phase IIb study in rheumatoid arthritis (RA).
"AbbVie supports the start of this innovative study in Crohn's disease with GLPG0634. Our experience within gastroenterology, combined with a novel alternative treatment for this disease, may provide a greater benefit to patients in the future," said Scott Brun, M.D., vice president of pharmaceutical development at AbbVie.
"Galapagos and AbbVie are moving forward with GLPG0634, expanding the scope of the development program into inflammatory bowel disease,” said Onno van de Stolpe, chief executive officer of Galapagos. “Galapagos is in a strong financial position to fund the Crohn's program, in addition to the phase IIb program with GLPG0634 in RA and our other proprietary clinical and pre-clinical programs.”