Galapagos cystic fibrosis program progresses towards therapy for largest patient group

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17/06/2014

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.

  • Review of CF and other highlighted programs in today's R&D update
  • 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

R&D strategy

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.

GLPG0634

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.

Anti-infectives program

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.

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