Date: 2012-12-03
Type of information: Initiation of preclinical development
phase: 1
Announcement: opening of an IND
Company: Galapagos (Belgium)
Product: GLPG0634
Action
mechanism: 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: USA
Trial details:
Latest
news: Galapagos has opened its Investigational New Drug application for GLPG0634 with the FDA. Galapagos intends to conduct a Phase 1 drug interaction study in the United States, which is expected to be completed in the first quarter of 2013. Acceptance of the IND was based on a review by the FDA of the GLPG0634 data package, including chemical/pharmaceutical data, preclinical data up to the formal 13-week toxicology studies and currently completed clinical studies. \"The FDA has reviewed all the GLPG0634 pre-clinical and clinical data to date and found these supportive of the conduct of our first clinical trial within the United States, said Piet Wigerinck, CSO of Galapagos. We will follow up with studies in rheumatoid arthrisis patients next year, and intend to include US study centers in our Phase 2b program.\"
