Gilead’s Novel Anti-inflammatory Drug Filgotinib Demonstrates Strong Efficacy in Methotrexate-Naïve Rheumatoid Arthritis Patients

March 29, 2019 News /BioValleyBIOON/ -- U.S. pharmaceutical giant Gilead and its partner Galapagos recently announced the results of filgotinib, an anti-inflammatory drug, in the treatment of rheumatoid arthritisRheumatoid Arthritis24-week data from the Phase III FINCH 3 study in rheumatoid arthritis (RA). The results showed that, in patients who had not previously received methotrexate (MTX) treatment, the combination therapy of filgotinib plus MTX demonstrated significant efficacy compared with MTX alone.

FINCH 3 was a randomized, double-blind, active-controlled, 52-week Phase III study that enrolled 1,252 adult patients with moderately to severely active rheumatoid arthritis (RA) who were naive to methotrexate (MTX) treatment (i.e., MTX-naïve), to evaluate the efficacy and safety of filgotinib as monotherapy and in combination with MTX. In the study, patients were randomized in a 2:1:1:2 ratio to receive: filgotinib 200 mg plus MTX (n=417), filgotinib 100 mg plus MTX (n=207), filgotinib 200 mg monotherapy (n=210), or MTX monotherapy (n=418). The primary endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at Week 24.

The results showed that the study met its primary endpoint. At Week 24 of treatment, the proportions of patients achieving an ACR20 response were significantly higher in both the filgotinib 200 mg + MTX group and the filgotinib 100 mg + MTX group compared with the MTX monotherapy group. The proportions of patients achieving ACR50 and ACR70 responses, as well as clinical remission (DAS28[CRP] < 2.6), were also significantly higher. Furthermore, at Week 24, patients receiving filgotinib demonstrated greater improvements in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores compared with those receiving MTX alone. At Week 24, filgotinib 200 mg monotherapy inhibited the progression of structural damage (assessed by the modified Total Sharp Score [mTSS]) compared with MTX.Detailed Efficacy Data Are Shown Below:

In this study, the safety profile of filgotinib was consistent with the 24-week safety results from previous studies. The proportions of patients experiencing serious adverse events in the filgotinib 200 mg + MTX, filgotinib 100 mg + MTX, filgotinib 200 mg, and MTX treatment groups were 4.1%, 2.4%, 4.8%, and 2.9%, respectively. The proportions of patients with serious infections were 1.0%, 1.0%, 1.4%, and 1.0%, respectively. During the study, one venous thrombotic event (in the MTX group), five major adverse cardiovascular events (two in the filgotinib 200 mg + MTX group, one in the filgotinib 200 mg group, and two in the MTX group), and one death (in the filgotinib 200 mg + MTX group) occurred. The proportion of patients reporting herpes zoster was 0.5% in each treatment group.

John McHutchison, Head of Research and Development and Chief Scientific Officer at Gilead Sciences, stated, “Inflammatory diseases are a key focus area for Gilead’s R&D efforts, and filgotinib is the cornerstone of this work. Results from the FINCH 3 study clearly demonstrate that filgotinib provides significantly improved efficacy compared with methotrexate (MTX) monotherapy in patients with early-stage rheumatoid arthritis (RA). These data reinforce the evidence from our broader FINCH clinical development program and underscore the potential of filgotinib to address important unmet medical needs in the RA patient population.”

Molecular structure of filgotinib (Image source: Wikipedia)

Filgotinib is a highly selective JAK1 inhibitor discovered and developed by Galapagos. In late December 2015, Gilead Sciences entered into an agreement with Galapagos worth up to $2 billion for the co-development of filgotinib. This collaboration will help strengthen Gilead’s position in the field of inflammatory diseases, which is poised to become a new growth driver for the company following its success in hepatitis C and HIV.

Currently, Gilead and Galapagos are conducting multiple studies to evaluate the potential of filgotinib in treating various inflammatory diseases, including Phase III studies for the treatment of rheumatoidRheumatoid Arthritis, Crohn's disease, ulcerative colitis.

Pharmaceutical market research firm EvaluatePharma previously released a report predicting that filgotinib would become one of the key products driving Gilead’s future growth, with global sales expected to reach $1.4 billion in 2024. (Bioon.com)

Original Source:Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients