Galapagos NV and AbbVie have announced an extension of their GLPG0634 clinical development collaboration to include Crohn's disease.
Galapagos will fund and complete a Phase 2 program in Crohn's disease, which is designed to facilitate rapid progression into Phase 3.
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 2, and completing regulatory and commercialization activities.
Galapagos will start an innovative 20-week, Phase 2A/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 2 study in Crohn's will be performed in parallel with the Phase 2B 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, including more than one million people in Europe and more than 500,000 people in the U.S.
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 anemia 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, M.D., vice president, pharmaceutical development, AbbVie.
"Galapagos and AbbVie are moving forward with GLPG0634, expanding the scope of the development program into inflammatory bowel disease. The innovative Phase 2 program in Crohn's disease is designed to move rapidly into Phase 3 when successful," said Onno van de Stolpe, CEO of Galapagos.
Stolpe continued, "Galapagos is in a strong financial position to fund the Crohn's program, in addition to the Phase 2b program with GLPG0634 in RA and our other proprietary clinical and pre-clinical programs. Our pipeline continues to mature in stage and scope, now that we have three Phase 2 molecules in five inflammatory indications, all with readouts by mid 2015 or earlier."