Galapagos NV (GLPG.BR) Cystic Fibrosis Program Progresses Towards Therapy For Largest Patient Group
6/17/2014 8:46:04 AM
• GLPG0634 DARWIN 1 study to deliver 12 week topline data in Q1 2015
• GLPG0974 shows biomarker effect & good safety in ulcerative colitis patients, but lacks clinical improvement in 4 week Proof-of-Concept study
• GLPG1492 mode of action scalable to ESKAPE and other pathogens
• Multiple Phase 2 readouts with novel modes-of-action in coming two years
Live webcast presentation today at 8:00 am ET/2:00 pm CET on www.glpg.com,
call number +32 2 404 0660, confirmation code 2952966
Mechelen, Belgium; 17 June 2014 - Galapagos NV (Euronext: GLPG) will give an R&D Update today in New York City, highlighting the company strategy, progress and plans for its portfolio of more than 35 R&D programs.
Galapagos selects diseases with large, unmet medical need and discovers novel mode-of-action medicines to address these diseases. The Company's R&D focus on inflammation, orphan, anti-infectives, and fibrosis has yielded a substantial pipeline with multiple Phase 2 readouts the coming two years. Galapagos seeks to partner programs at an optimal stage, with the ambition to ring fence certain proprietary programs.
Selective JAK1 inhibitor GLPG0634 has shown a best-in-class profile in two rheumatoid arthritis Phase 2 studies. GLPG0634 is currently in a global Phase 2b program (DARWIN) in 875 rheumatoid arthritis patients and a Phase 2 study in 180 patients with Crohn's disease. Due to longer than anticipated approval rounds with national regulators, topline 12 week results for DARWIN 1 (595 patients, methotrexate add-on) are expected in Q1 2015, DARWIN 2 (280 patients, monotherapy) topline 12 week results are expected in Q2 2015, with complete 24 week data package expected in Q3 2015. Topline data from the Phase 2 study in Crohn's disease remains on track for disclosure in Q2 2015. AbbVie will base its licensing decision on the complete 24 week DARWIN data package from GLPG0634.
GLPG0974 topline results
GLPG0974 is the first selective antagonist of FFA2 to be tested in the clinic. GLPG0974 showed good results in Phase 1 studies and recently completed a 4-week Phase 2 proof-of-concept study in 45 ulcerative colitis (UC) patients in 16 centers in 4 European countries. Patients received 200 mg of GLPG0974 twice-daily for 4 weeks. Patients on treatment tolerated it well and showed a decrease in fecal calprotectin, a byproduct of neutrophil breakdown in the gut, as well as a decrease in the number of infiltrating neutrophils. These biomarker reductions are evidence for the novel mode-of-action directed toward neutrophil migration. Reduction in neutrophil influx did not translate to improvement in signs and symptoms during this four week study. Galapagos is performing subgroup analyses, exploring additional indications, and discussing further development of GLPG0974 with potential partners.
Cystic fibrosis programs
In addition to potentiator GLPG1837, Galapagos and its partner AbbVie have discovered multiple series of correctors that show better activity than VX-809 in pre-clinical tests in the f508del mutation, which affects 87% of CF patients. Multiple corrector-potentiator combinations are under development that restore up to 65% of healthy (wild type) CFTR activity in cells with the f508del mutation. GLPG1837 is expected to enter the clinic by end 2014. A first corrector pre-clinical candidate nomination is also expected this year.
Galapagos has a fully proprietary narrow spectrum antibiotic with a novel mode-of-action against Methicillin-resistant Staphylococcus aureus, GLPG1492, which is expected to be dosed in first volunteers (Phase 1) in the second half of 2014. Galapagos will highlight pre-clinical data with GLPG1492 showing in vitro cidality and in vivo efficacy, with broad coverage of all known MRSA strains. Galapagos has discovered that the mode of action for GLPG1492 can be utilized as a platform for addressing gram positive and gram negative bacteria posing major public health threats, including the ESKAPE pathogens.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public today at 8:00 AM Eastern/14:00 Central European Time (CET), which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
Confirmation Code: 2952966
Conference call numbers
Local - Brussels, Belgium:
+32 2 404 0660
Local - New York, USA: +1 646 254 3362
National free phone - USA: +1 877 280 2296
National free phone - Belgium: 0800 58033
A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising five Phase 2 studies (two led by GSK), one Phase 1 study, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. 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 in Phase 2 in Crohn's disease. Galapagos has another selective JAK1 inhibitor in Phase 2 in ulcerative colitis 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 has completed a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. AbbVie and Galapagos signed an agreement in CF whereby they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. Potentiator GLPG1837 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
For media and investor inquiries:
Elizabeth Goodwin, Head of Corporate Communications & Investor Relations
Tel: +31 6 2291 6240
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