Mechelen, Belgium; 30 January 2013 – Galapagos NV (Euronext: GLPG) announced today that it has been awarded a €2.5 million grant from the Flemish agency for Innovation by Science and Technology (IWT) for inflammatory bowel disease (IBD) research and development. The goal of this 2.5-year project is to identify new therapeutic compounds for future treatment of IBD patients.
Inflammatory bowel disease (IBD) is a chronic, uncontrolled inflammation of the intestinal mucosa. Crohn’s disease (CD) and ulcerative colitis (UC) are the two main types of IBD; both diseases have an autoimmune component. The introduction of anti-TNF alpa antibodies has changed the treatment of refractory patients, but only one third of the patients will achieve long-term remission. As such, the medical need in this patient segment is very high.
The general purpose of the IWT-funded program is to gain better insight in the roles of GPR43 and two undisclosed targets in the pathobiology of chronic inflammatory disorders, in order to understand their therapeutic value. Galapagos will collaborate in this project with Professor Dr Paul Rutgeerts and Professor Dr Séverine Vermeire from the Catholic University of Leuven, and the research group of Professor Dr Martine De Vos at Ghent University.
Galapagos has been working in the anti-inflammatory field for a long time, and has several projects with IBD as potential indication. The first compound that will be tested in IBD patients is GLPG0974, an inhibitor of target GPR43 (also known as FFA2). This target is one of the three whose role in IBD will be investigated in this IWT-funded project. Galapagos has recently completed a second Phase I clinical study with GLPG0974, and results are expected to be reported later this quarter. In April Galapagos will start a Proof of Concept study with GLPG0974 in UC.
“After RA, IBD is the second autoimmune disease focus for Galapagos. With this grant we will get a better understanding of the cause of IBD, and this will contribute to the search for better medicines,” said Piet Wigerinck, CSO of Galapagos. “The knowledge that will come from this research will provide more insight into the potential of our programs for use in this indication.”
Inflammatory bowel diseases (IBD) are disorders of multi-factorial cause that present as a multitude of phenotypes, clinical behaviors and severity. Crohn’s disease (CD) and ulcerative colitis (UC) are the two main types of IBD. The peak age of onset is 15 to 30 years old, with a second, smaller peak occurring in individuals aged 50 to 70, with the prevalence rate of IBD reaching up to 396/100,000 persons.
The hallmark of IBD is chronic uncontrolled inflammation of the intestinal mucosa, involving a pathological response in both innate and adaptive immune system. The pathogenesis is an interplay of factors as diverse as genetic susceptibility, the external environment, infectious agents, the commensal enteric microbiota, and (mucosal) immune system dysfunction. However, the current understanding of the pathogenesis remains limited. The characteristic inflammatory response begins with infiltration of neutrophils and macrophages, which release chemokines and cytokines. These in turn exacerbate the dysfunctional immune response and activate cellular and humoral responses in the gut mucosa.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size clinical stage biotechnology company specialized in the discovery and development of small molecule and antibody therapies with a novel mode-of-action. The Company is progressing four clinical, six pre-clinical, and 30 discovery programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
Its lead program is GLPG0634, an orally-available, selective inhibitor of JAK1, for the treatment of rheumatoid arthritis and potentially other inflammatory diseases. In two four-week Phase 2 studies, GLPG0634 showed improvement in the signs and symptoms of rheumatoid arthritis and a unique safety profile. A 6-month Phase 2b study is expected to start Q2 2013 with topline data expected in Q4 2014. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2b. Galapagos is also progressing two other clinical development programs with clinical readouts expected in 2013: GLPG0187, a novel integrin receptor antagonist in development for metastasis, is in a Phase 1b patient study; GLPG0974 is the first inhibitor of GPR43, which is currently often referred to as FFA2. It will be evaluated for the treatment of IBD. This program is in Phase 1 and a Proof of Concept Phase 2 study will start in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has over 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information about the company and its drug development programs can be found online at: www.glpg.com
Dr Piet Wigerinck, Chief Scientific Officer
Tel. +32 477 627103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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