Galapagos announces completion of patient enrollment for DIVERSITY Phase 3 study with filgotinib in Crohn’s Disease
October 04, 2021 01:01 ET | Source: Galapagos NV
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1,374 patients enrolled into the phase 3 study across 369 global sites
Topline data anticipated in H1 2023
Galapagos will assume responsibility for the DIVERSITY study
Mechelen, Belgium; 4 October 2021, 07.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced randomization of the last patient into the multi-center, global DIVERSITY Phase 3 study. The study is designed to evaluate the efficacy and safety of filgotinib, a JAK1 preferential inhibitor, in the induction and maintenance of remission in patients with Crohn’s Disease (CD).
The DIVERSITY study enrolled 1,374 participants with moderately to severely active CD, including biologic-naïve and biologic-experienced patients. The study evaluates the safety and efficacy of 100mg and 200mg filgotinib versus placebo on clinical remission and endoscopic response, in a 10-week induction phase, followed by a 47-week maintenance phase. Topline results of the DIVERSITY study are anticipated in H1 2023.
Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos NV said: “This is an important milestone in the DIVERSITY program, as it brings us closer to delivering robust evidence to assess the use of our JAK1 preferential inhibitor as a potentially new class of medicine in the treatment of patients with Crohn's Disease. I would like to thank the patients and the clinical trial centers for participating in this important program, especially during the recent COVID-19 pandemic, which has been a particularly challenging time for the health services and society as a whole.”
The DIVERSITY clinical program design was informed by results from the Phase 2 FITZROY study, with filgotinib, which provided positive results for the use of this JAK1 inhibitor in patients with active CD. Full results were reported in The Lancet.1
The use of filgotinib for CD is investigational and is not approved anywhere globally.
Galapagos will assume operational and financial responsibility for DIVERSITY
In agreement with Gilead, Galapagos will assume sponsorship of and operational and financial responsibility for the ongoing DIVERSITY clinical study, evaluating filgotinib in CD, and its long-term extension study. The parties intend to complete the transfer no later than June 30, 2022. Under the terms of the agreement and upon completion of the transfer, Gilead will make a one-time payment of $15 million to Galapagos in consideration for Galapagos assuming responsibility for the DIVERSITY clinical study. From April 1, 2022, Galapagos will also be solely responsible for all development costs for the DIVERSITY clinical study. In addition, if the European Medicines Agency grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial, then royalties payable by Galapagos to Gilead will be reduced by 30% across all filgotinib indications and will become 5.6 to 10.5% of net sales in Europe. These royalties are payable as of 2024. Gilead remains responsible for commercial activities outside of Europe.
About Crohn’s Disease
Crohn’s disease is a type of inflammatory bowel disease in which the well-controlled balance of the intestinal immune system is disturbed. CD causes ulcerations that may affect any part of the digestive system from mouth to anus. The cause of the disease is unknown, with onset usually between the ages of 15 and 35. Patients suffer from abdominal pain, diarrhea (often blood), vomiting, fever and weight loss. Estimates suggest there could be up to 1.6 million people living with CD across Europe and up to 78,000 new cases every year.2
About the DIVERSITY Phase 3 Study
DIVERSITY consists of a combined, double-blind, placebo-controlled Phase 3 study, enrolling 1,374 patients from 369 centers worldwide. The study compares the efficacy of filgotinib 100mg or 200mg once-daily oral treatment versus placebo in the induction and maintenance of clinical remission measured by Crohn’s Disease Activity Index (CDAI) score and endoscopic response measured as simple endoscopic score for Crohn’s Disease (SES-CD) at week 10 and week 58, in biologically-naive and biologically-experienced patients with moderately to severely active CD. There are EU-specific co-primary objectives that evaluate clinical remission measured by Patient Reported Outcome (PR02) and endoscopic response (SES-CD) at Week-10 and Week-58. In addition to clinical endpoints the study will also evaluate the effects on Health-Related Quality of Life (HRQoL) scores and Health Care Resource Utilization (HCRU) at Week-10 and Week-58. Safety will be evaluated by assessment of clinical laboratory tests, physical examination, vital signs measurements at various timepoints during the study, and by the documentation of Adverse Events.