Galapagos NV is a clinical stage biotechnology company specialized in small molecule therapies that is developing medicines with novel mechanisms of action. The company has recently announced that the last patient in their DARWIN 1 trial treated with filgotinib has completed 12 weeks of therapy. Now that dosing in the last patient for the 12-week period has been completed, investigators will begin to process the data collected from all 599 patients that enrolled in the study. The process will take about 7 or 8 weeks and the company expects to release top line results in April 2015.
Filgotinib, the JAK1 inhibitor, has revealed an excellent potential profile in 2 four-week Phase 2A trials in rheumatoid arthritis patients. Filgotinib is part of a global Phase 2B program (DARWIN 1, 2 and 3) that includes 886 participants suffering with rheumatoid arthritis as well as a Phase 2 trial enrolling 180 patients with Crohn’s disease.
DARWIN 1 is a placebo-controlled, double-blind, 24-week trial that includes 599 patients suffering with moderate to severe rheumatoid arthritis that responded to methotrexate inadequately. During the trial, all patients remain on their background therapy of methotrexate. The trial intends to evaluate 3 doses of filgotinib, administered once per day and twice per day. In April Galapagos hopes to report the top line results regarding the initial 12 weeks of treatment, whereas the trial will continue for another 12 weeks of treatment. The top line outcomes from the 24-week treatment in DARWIN 1 is expected to be available in July 2015.
The 12-week treatment results for DARWIN 1 will include non blinded ACR20 (primary endpoint) scores and other significant secondary endpoints, as well as further important safety and lab information. Severe adverse events and the frequency of rare events will be disclosed but will remain blinded until the 24 week treatment data is out to ensure the double-blind character of the DARWIN program.
“We look forward to the 12 week topline results of DARWIN 1 in mid-April. We see 98% of eligible patients who complete DARWIN 1 and 2 enrolling in DARWIN 3, with 400 patients now in the long term extension study. The fact that investigators and patients see benefit in continuing treatment with filgotinib gives confidence,” said Piet Wigerinck, Galapagos’ CSO.
Read other news about Galapagos NV’s other clinical trials for rheumatoid arthritis.