Galapagos NV products

Filgotinib, a preferential JAK1 inhibitor, is marketed as Jyseleca in the European Union (incl. Norway), Great Britain, and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

A TYK2 inhibitor for which topline results from the Phase 1b in psoriasis were reported in July 2021. Phase 2 studies in dermatomyositis and Systemic Lupus Erythematosus (SLE) are expected to start in 2023.

The SIK program is a strategic effort to develop assets inhibiting salt-inducible kinases (SIK) as a novel target class in inflammation which we discovered with our proprietary target discovery platform. These molecules inhibit the different members of the SIK family and have shown the potential to modulate anti-inflammatory cytokines and pro-inflammatory cytokines. Targeted and selective inhibition of SIK proteins brings an opportunity to restore the immune balance that is typically out of balance in autoimmune diseases. .We have observed encouraging activity in various inflammatory preclinical models with compounds targeting this class.

GlaxoSmithKline exercised its option to exclusively license investigational compound GLPG0778 and its corresponding back-up compound GLPG0555, both discovered and developed within GSKs immuno-inflammatory alliance with Galapagos. GSK has all rights to these compounds, and Galapagos is eligible to receive milestones and up to double-digit royalties on global sales. In the course of 2013, GSK initiated Phase 2 studies with GSK2586184 (formerly GLPG0778) in systemic lupus erythematosus, chronic plaque psoriasis, and ulcerative colitis. In February 2014, GSK stopped the lupus study due to a lack of effect and put the ulcerative colitis study on hold. In April 2014,

GLPG2737 is a Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) inhibitor which was observed to be well tolerated by patients in previous clinical trials. It is hypothesized that inhibition of the CFTR channel might reduce cyst growth and enlargement for patients with autosomal dominant polycystic kidney disease (ADPKD). In December 2020, we announced the first dosing with GLPG2737 in the Phase 2 MANGROVE trial in patients with ADPKD and in November 2021 full patient recruitment with topline results anticipated in the first half of 2023.