NEW ANALYSES OF PHASE 2 EQUATOR CLINICAL PROGRAM SUPPORT DURABLE EFFICACY OF FILGOTINIB IN PSORIATIC ARTHRITIS

-- Data Were Presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020 --

Foster City, Calif., & Mechelen, Belgium, 5 June 2020, 22.01 CET – Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA). The data from the double-blind, placebo-controlled, Phase 2 EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA. The new analyses were presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.

“Despite existing treatments, people living with psoriatic arthritis can face challenging long-term symptoms including joint swelling and stiffness, pain and fatigue – all of which can significantly impact patients’ daily lives,” said Mark Genovese, MD, Senior Vice President, Inflammation, Gilead Sciences. “These new analyses from the EQUATOR study program showed that patients with PsA treated with filgotinib achieved a sustained response. We look forward to advancing the pivotal Phase 3 PENGUIN clinical trial program to confirm the safety and efficacy of filgotinib as a potential treatment option for this patient population.”

“The data from the Phase 2 program for filgotinib in psoriatic arthritis add to the growing body of evidence for the efficacy and safety profile of this investigational treatment,” said Walid Abi-Saab, MD, Chief Medical Officer, Galapagos. “We are particularly encouraged by the innovative analysis of the impact of filgotinib at the molecular level, which indicates the drug is acting rapidly to reduce the hallmarks of inflammation in this condition.”

Efficacy and safety of filgotinib in patients with active PsA: Subgroup analyses from a randomized, placebo-controlled, Phase 2 trial (EQUATOR) (Poster #0343)¹
In a new subgroup analysis of patients with active PsA in the 16-week EQUATOR Phase 2 trial, the effects of filgotinib on key efficacy endpoints were generally consistent across a range of patient subgroups, including sex, body mass index, disease duration, baseline disease severity, concurrent use of disease-modifying antirheumatic drugs and prior exposure to tumor necrosis factor inhibitors.