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POSITIVE TRIAL RESULTS WITH FILGOTINIB IN PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS BOTH PUBLISHED IN THE LANCETPhase 2 EQUATOR Data Demonstrating Efficacy in Psoriatic Arthritis Also Presented in a Plenary Session at 2018 ACR/ARHP Annual Meeting Chicago, October 22, 2018; 19.15 CET - Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR data also coincides with a plenary session presentation at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting. "The results of the EQUATOR and TORTUGA studies demonstrate that filgotinib improved the signs and symptoms of patients with psoriatic arthritis whose disease had not responded to prior therapies and independently, for those with ankylosing spondylitis," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "These findings represent an important step forward in our efforts to improve outcomes for people living with these inflammatory diseases." "We are pleased that filgotinib demonstrates a consistent safety and efficacy profile across multiple inflammatory conditions, including psoriatic arthritis and ankylosing spondylitis," said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. "We look forward to sharing additional updates as we continue to develop this compound for patients in need of additional therapy options." Phase 2 EQUATOR Study in Psoriatic Arthritis [ACR/ARHP Abstract #1821] Data from EQUATOR, a placebo-controlled trial of 131 adults with moderately to severely active psoriatic arthritis who had an inadequate response or were intolerant to at least one conventional disease-modifying anti-rheumatic drug (cDMARD), demonstrated the efficacy of filgotinib in this patient population. The study achieved its primary endpoint at Week 16, with 80 percent of patients on filgotinib 200mg once-daily achieving ACR20, compared with 33 percent on placebo (p<0.001). ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib compared with placebo (ACR50: 48 percent for filgotinib vs 15 percent, p<0.001; ACR70: 23 percent vs 6 percent, p<0.01). These data were previously announced in May 2018. The study also found greater improvement in disease signs and symptoms for patients receiving filgotinib 200mg once-daily compared with placebo at Week 16, as measured by Minimal Disease Activity (MDA) (23 percent vs 9 percent, p<0.05) and the Psoriasis Area and Severity Index 75 percent improvement from baseline (PASI75) (45 percent vs 15 percent, p<0.01). The data showed greater improvement from baseline in the Health assessment questionnaire disability index (HAQ-DI) for those receiving filgotinib compared with placebo (-0.57 vs -0.28, p<0.001). Safety-related outcomes were similar between the filgotinib and placebo arms of the study, including rates of treatment-emergent adverse events (57 percent and 59 percent, respectively) and infections and infestations (22 percent and 21 percent). Two serious treatment-emergent adverse events were reported: one hip fracture in the placebo group and one case of fatal pneumonia in the filgotinib treatment group, which was the only serious infection and the only death in the study. No deep venous thrombosis, pulmonary embolism, malignancies, gastrointestinal perforations, opportunistic infections/active tuberculosis, or cases of Herpes zoster were reported. "Effective treatment for psoriatic arthritis is critical for relieving pain and inflammation and helping to prevent joint damage. Unfortunately, not all patients respond to currently available therapies," said Philip J. Mease, MD, Director of Rheumatology Research, Swedish-Providence-St. Joseph Health Systems and Clinical Professor, University of Washington. "These results indicate that filgotinib has the potential to address the needs of individuals who require additional treatment options." Phase 2 TORTUGA Study in Ankylosing Spondylitis In the Phase 2 TORTUGA study, adults with moderately to severely active ankylosing spondylitis who were treated with filgotinib 200mg once-daily achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12. The mean change from baseline in ASDAS was -1.5 for patients treated with filgotinib versus -0.6 for those treated with placebo (p<0.0001). ASAS20 and ASAS40 responses at Week 12 were also significantly higher for filgotinib compared with placebo (ASAS20: 76 percent for filgotinib vs 40 percent for placebo, p<0.0001; ASAS40: 38 percent vs 19 percent, p<0.05). Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups (31 percent). Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event of pneumonia reported for a patient receiving filgotinib who recovered after hospital-based antibiotic treatment. One patient with an inherited risk for thrombosis who was randomized to filgotinib experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, gastrointestinal perforations, opportunistic infections/active tuberculosis, or cases of Herpes zoster were reported. Full results of both studies are now available in The Lancet: Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32483-8/fulltext Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32463-2/fulltext Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov. About the EQUATOR Trial The primary objective of EQUATOR was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of psoriatic arthritis, as assessed by the proportion of patients achieving ACR20 at Week 16. Secondary objectives included the proportion of patients achieving ACR50/70 and MDA as well as the effects of filgotinib on psoriasis, dactylitis (whole finger inflammation), and enthesitis (inflammation of the tendons). About the TORTUGA Study About the Galapagos - Gilead Collaboration Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Filgotinib is being investigated in several clinical trials in inflammatory diseases, including the Phase 3 trials in rheumatoid arthritis FINCH 1, 2 and 3, the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn's disease (also small bowel and fistulizing Crohn's disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis. About Galapagos Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, cystic fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 675 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com. About Gilead Sciences Galapagos Forward-Looking Statement Gilead Forward-Looking Statement Galapagos Contacts Investors: Media: Elizabeth Goodwin Evelyn Fox VP IR & Corporate Communications Director Communications +1-781-460-1784 +31 6 53 591 999 E-mail: [email protected] E-mail: [email protected]
Sofie Van Gijsel Director IR +32 485 191415 E-mail: [email protected]
Gilead Contacts Investors: Media: Sung Lee Nathan Kaiser +1 650-524-7792 +1 650-522-1853 Attachment |