NORTH CHICAGO, Ill. and MECHELEN, Belgium—AbbVie and Galapagos NV on May 17 announced an extension of their GLPG0634 clinical developmentcollaboration to include Crohn's disease. Galapagos will fund andcomplete a Phase II program in Crohn's disease, which is designed tofacilitate rapid progression into Phase III. Upon successful completionof the study, expected in the second quarter of 2015, AbbVie will pay Galapagos $50 million.
The terms of the collaboration extension are in addition to previouslyagreed upon financial terms. AbbVie will be responsible for fundingand performing clinical development beyond Phase II, and completingregulatory and commercialization activities.
Galapagos will launch a 20-week, Phase IIA/B study with GLPG0634 in 180 patientssuffering from Crohn's disease by early 2014. Researchers will be looking both at induction of disease remission and "early maintenance of itsbeneficial effects in Crohn's disease," the company says. This Phase II study in Crohn's disease willbe performed in parallel with the Phase IIB study in rheumatoid arthritis(RA).
"Galapagos is in a strong financial position to fundthe Crohn's program, in addition to the Phase IIb program with GLPG0634in RA and our other proprietary clinical and preclinical programs," said Onno van de Stolpe,CEO of Galapagos. "Ourpipeline continues to mature in stage and scope, now that we have threePhase II molecules in five inflammatory indications, all with readoutsby mid-2015 or earlier."
The Janus kinases (JAK) are afamily of enzymes that play a key role in the signaling mechanism usedby a number of cytokines that are involved in autoimmune diseases such as Crohn's. Because of the immune-modulating characteristics of JAKinhibitors, they are seen as having good potential totreat Chrohn's.
According to the companies, by inhibitingJAK1, GLPG0634 blocks signaling for several key pro-inflammatorycytokines such as interleukin 6 (IL-6). Its selective JAK1 inhibitionprofile reportedly avoids inhibition of JAK2 which offers what the companies call "a unique advantage" inCrohn's disease and a potentiallybetter safety profile than other JAK inhibitors.
That's because inhibition of JAK2 has resulted in anemia and reducedformation of blood cells in clinical studies with other JAK inhibitors, and this is a concern when dealing with patients who have inflammatory boweldisease because blood loss through gastrointestinal bleeding often alreadycauses anemia in these patients.
"Our experience within gastroenterology, combined with a novelalternative treatment for this disease may provide a greater benefit topatients in the future," said Fr. Scott Brun, vice president of pharmaceutical development at AbbVie.