AbbVie and Galapagos have extended their collaboration on the clinical development of GLPG0634 to include Crohn's disease. Under the terms of the collaboration, in addition to previously agreed upon financial terms, Galapagos will fund and complete a Phase II program in Crohn's disease, designed to facilitate rapid progression into Phase III. The Phase II study is expected to complete in the second quarter of 2015 and AbbVie will pay Galapagos $50 million upon successful completion. AbbVie will fund and conduct clinical development programs beyond Phase II, including regulatory and commercialization activities.
A 20-week Phase II A/B study evaluating GLPG0634 in 180 patients with Crohn's disease will begin in early 2014. Induction of disease remission and early maintenance of the agent’s beneficial effects in Crohn's disease will be measured as study endpoints, with topline results expected in the second quarter of 2015. Galapagos will conduct this Phase II trial in parallel with a Phase IIB study in rheumatoid arthritis (RA) patients.
Crohn's disease is a serious chronic, inflammatory autoimmune disease of the gastrointestinal (GI) tract affecting more than one million people in Europe and more than 500 000 people in the US. Janus kinase (JAK) enzymes play a key role in the signaling of several cytokines involved in autoimmune diseases. JAK inhibitors have the potential to become effective treatment options because of their immune-modulating effects.
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. By inhibiting JAK1, GLPG0634 blocks signaling for several key pro-inflammatory cytokines such as interleukin 6 (IL-6).
"Galapagos and AbbVie are moving forward with GLPG0634, expanding the scope of the development program into inflammatory bowel disease. The innovative Phase II program in Crohn's disease is designed to move rapidly into Phase III when successful," said Onno van de Stolpe, CEO of Galapagos, in a press statement. "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 preclinical programs. Our pipeline continues to mature in stage and scope, now that we have three Phase II molecules in five inflammatory indications, all with readouts by mid 2015 or earlier."
"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, MD, vice president, pharmaceutical development, AbbVie.