Date: 2015-09-25
Type of information: Results
phase: 2b
Announcement: results
Company: Galapagos (Belgium)
Product: GLPG0634 (filgotinib)
Action
mechanism: enzyme inhibitor/janus kinase inhibitor. GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling 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.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On September 25, 2015, Galapagos announced that the Company will be moving filgotinib, its highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016. Filgotinib has shown best-in-class efficacy and safety in the DARWIN Phase 2B studies in rheumatoid arthritis and is now fully owned by Galapagos. Galapagos has demonstrated that high selectivity for JAK1 results in excellent efficacy and safety in rheumatoid arthritis patients. Based on our own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is three-fold more JAK1 selective than ABT-494. Galapagos reported best-in-class efficacy and safety in 24-week Phase 2B studies in 877 patients with filgotinib. Furthermore, Galapagos has more than 700 patient-years of treatment experience with filgotinib in RA patients, of which more than 500 years at the highest 200 mg dose, all with a clean safety profile consistent with JAK1 inhitbition: filgotinib showed a clear dose dependent increase in hemoglobin concentration without any impact on NK cells and lymphocyte counts. On efficacy, Galapagos consistently has reported ACR scores using the most conservative NRI approach. The table below shows the ACR scores for the DARWIN 1 study at 24-weeks on the LOCF basis, for comparison purposes DARWIN1 (MTX-IR) ACR20 ACR50 ACR70 50mg, once-daily 61* 35** 22* 100mg, once-daily 74*** 54*** 38*** 200mg, once-daily 78*** 55*** 31** 25mg, twice-daily 62* 38** 22* 50mg, twice-daily 66* 38** 25* 100mg, twice-daily 87*** 62*** 43*** placebo 45 16 9 * p< 0.05 vs. placebo; ** p Galapagos also announced that AbbVie has notified the company of termination of the agreement on filgotinib.
