Novel proprietary series to start clinical trials end of 2014
Superior CFTR channel opening shown in cells from CF patients
Favorable ADME/PK profile and selectivity
Mechelen, Belgium; 17 October 2013 – Galapagos NV (Euronext: GLPG) has developed a series of novel potentiators in its cystic fibrosis program. The data will be presented at the North American Cystic Fibrosis Conference taking place from 17 – 19 October in Salt Lake City, Utah.
In its CF research program, Galapagos developed novel potentiator series that are highly potent and that show superior opening of the defective CFTR channel in comparison to Kalydeco®. This was shown in assays of cells that carry a CFTR class II, III or IV mutation. Furthermore, the superior channel opening was confirmed in primary cells from F508del and G551D patients. In addition to its efficacy, the Galapagos series show good metabolic stability and permeability and favorable PK profiles. In comparison to Kalydeco®, the new potentiators have a superior in vitro safety profile, including a clean CYP profile and high selectivity. These results encourage Galapagos to nominate a pre-clinical candidate from this series at the end of this year, with the first clinical trials starting at the end of 2014. Galapagos has pending patents on these novel potentiators.
Galapagos initiated its research in CF in 2005 as part of a collaboration with the Cystic Fibrosis Foundation. In 2010 Galapagos decided to pursue CF as the first orphan disease in which the company is attempting to discover, develop and launch its own medicines. In September 2013 Galapagos signed an agreement with AbbVie where they will work collaboratively to develop and commercialize oral drugs that address the main mutations in CF patients, including F508del and G551D. Galapagos will present its novel potentiators at a poster session (abstract #41) at NACFC on 17 October at 11:50 am and 18 October at 4 pm and is available online at www.glpg.com.
About Cystic Fibrosis
Cystic fibrosis (CF) is a hereditary disease of the entire body which leads to severe disability and early death in many cases. Symptoms include frequent lung infections, sinus infections, poor growth, and diarrhea. The cause is a defect in gene which encodes for cystic fibrosis transmembrane conductance regulator (CFTR), a protein which regulates components of sweat, mucus, and digestive juices. CF affects approximately 70,000 people worldwide. Patient symptoms are treated with antibiotics and other medicines. There currently is no cure for the disease, and the predicted median age of survival is in the late 30s. For more information about cystic fibrosis, visitwww.cff.org.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of five Phase 2 (two led by GSK), one Phase 1, six pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
AbbVie and Galapagos signed an agreement in CF where they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. In the field of inflammation, AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and about to enter Phase 2 studies in Crohn’s disease. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and is currently in a First-in-Human Phase 1 study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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