Mechelen, Belgium; 1 July 2013 - Galapagos NV (Euronext: GLPG) announced today that the first rheumatoid arthritis (RA) patients have been screened for enrolment in the Phase 2B clinical program with GLPG0634, a selective JAK1 inhibitor. The DARWIN Phase 2B program includes two dose finding studies and an open label extension study. The dose finding studies will evaluate the efficacy and safety of GLPG0634 with 24 weeks of treatment in 875 moderate to severe RA patients refractory to methotrexate.
GLPG0634 is the first selective JAK1 inhibitor in development for RA. The results of two 4-week Phase 2A clinical studies demonstrated the rapid clinical benefit and favorable safety profile of the drug, and supported the selection of the GLPG0634 doses that will be evaluated in the current Phase 2B program. Galapagos started the 24-week global DARWIN Phase 2B program in RA to identify the dose and dose-regimen that offers optimal efficacy and safety of GLPG0634 in patients with moderate to severe RA. Galapagos expects to report completion of recruitment by mid-2014 and 12-week topline data from the Phase 2B program in Q4 2014.
"GLPG0634 has shown a rapid suppression of disease activity with a good safety profile in the 4-week Phase 2A studies in RA patients. We look forward to seeing the effect of GLPG0634 in a global study, for a longer treatment period, and in a larger and more diverse patient population. The first patients will be recruited in Belgium and New Zealand," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Galapagos is on track in the RA program and is now also preparing for a Phase 2 study with GLPG0634 in Crohn's disease, which will run in parallel with the Phase 2B study in RA. By early 2014, we will have Phase 2 programs with GLPG0634 in RA and Crohn's, both with final readouts before mid-2015."
Details of the DARWIN Phase 2B program
The Phase 2B program, named DARWIN (Drug Against Rheumatoid Arthritis With Selective JAK1 INhibition) includes 2 dose finding studies, DARWIN 1 and DARWIN 2, and an open label extension study, DARWIN 3. All patients will have received methotrexate (MTX) but no longer have an adequate therapeutic response to this first-line therapy in RA. Patients will not have been exposed to prior biological treatments.
DARWIN 1 will enroll 595 patients who will continue their stable therapy of MTX while receiving GLPG0634 or placebo, whereas in DARWIN 2, 280 patients will stop MTX and receive monotherapy of GLPG0634 or placebo. All patients who receive placebo or low dose GLPG0634 and do not show improvement after 12 weeks of treatment will be randomized to a higher dose of GLPG0634. After completion of 24 weeks in either DARWIN 1 or 2, patients may continue open-label GLPG0634 as part of DARWIN 3, an extension study that will collect long-term safety and efficacy data.
GLPG0634 doses in DARWIN 1 and 2 will be 50, 100 and 200 mg per day. In DARWIN 1, these doses will be given as once-daily and twice-daily regimens (daily doses split in two), whereas only once-daily dosing will be evaluated in DARWIN 2. The DARWIN program will recruit patients from Europe, the Americas, Australia, and New-Zealand.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signalling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary program. Upon successful completion of the Phase 2B studies in RA, AbbVie will license the program and will assume sole responsibility for Phase 3 clinical development and global manufacturing.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of four clinical, seven pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
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. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2B. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1B patient study in metastasis. 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.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Piet Wigerinck, SVP Development
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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