Galapagos NV and AbbVie, a global, research-based biopharmaceutical company, have extended their GLPG0634 clinical development collaboration to include Crohn's disease. Galapagos will fund and complete a phase II programme in Crohn's disease, which is designed to facilitate rapid progression into phase III.

Upon successful completion of the study, expected in Q2 2015, AbbVie will pay Galapagos $50 million. The terms of the collaboration extension are in addition to previously agreed upon financial terms. 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 disease by early 2014.  The study will measure both induction of disease remission and early maintenance of its beneficial effects in Crohn's disease, and is expected to read out topline results in Q2 2015. This phase II study in Crohn's disease will be performed in parallel with the phase IIB study in rheumatoid arthritis (RA).

Crohn's disease is a serious chronic, inflammatory autoimmune disease of the gastrointestinal (GI) tract that affects millions of people worldwide. The Janus kinases (JAK) are a family of enzymes that play a key role in the signaling mechanism used by a number of cytokines that are involved in autoimmune diseases. JAK inhibitors, with their immune-modulating effects, have the potential to become an effective treatment option for this disease. By inhibiting JAK1, GLPG0634 blocks signaling for several key pro-inflammatory cytokines such as interleukin 6 (IL-6). Its selective JAK1 inhibition profile avoids inhibition of JAK2 which offers a unique advantage in Crohn's disease. Inhibition of JAK2 has shown anaemia and reduced formation of blood cells in clinical studies with other JAK inhibitors, which is a particular concern in patients with inflammatory bowel disease, as blood loss through gastrointestinal bleeding often already causes anemia in these patients. Therefore, GLPG0634 may potentially support a better safety profile than other JAK inhibitors.

"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.

"Galapagos and AbbVie are moving forward with GLPG0634, expanding the scope of the development programme into inflammatory bowel disease. The innovative phase II programme in Crohn's disease is designed to move rapidly into phase III when successful," said Onno van de Stolpe, CEO of Galapagos. "Galapagos is in a strong financial position to fund the Crohn's program, in addition to the phase IIb programme with GLPG0634 in RA and our other proprietary clinical and pre-clinical programmes. 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."

GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signalling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary programme. Upon successful completion of the phase IIb studies in RA, AbbVie will license the programme and will assume sole responsibility for phase III clinical development and global manufacturing.

Crohn's disease is a type of inflammatory bowel disease in which the well-controlled balance of the intestinal immune system is disturbed. The disease causes ulcerations of the small and large intestines in particular, but may affect any part of the digestive system from mouth to anus. The cause of the disease is unknown, with onset usually between the ages of 15 and 35. Patients suffer from abdominal pain, diarrhoea (often bloody), vomiting, fever, and weight loss. There is no cure for Crohn's disease; treatment options today are restricted to controlling symptoms, maintaining remission, and preventing relapse by the use of drugs that suppress the inflammation or the immune system, antibiotics, and eventually surgical removal of the inflamed bowels.

AbbVie is a global, research-based biopharmaceutical company and its mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.

Galapagos is specialized in novel modes-of-action, with a large pipeline of four clinical, seven pre-clinical, and 30 discovery small-molecule and antibody programmes in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.