Mechelen, Belgium; 23 February 2015 - Galapagos NV (Euronext: GLPG), a clinical stage biotechnology company focused on developing novel mode of action medicines, announces that the last patient in the DARWIN 1 trial with filgotinib has completed the 12 week visit. This last patient's 12 week visit triggers the clinical research organization's process of final 12 week data collection from all 599 patients enrolled in the trial, to be followed by database lock and analysis. As this process takes approximately 7 to 8 weeks, Galapagos expects to announce topline results by mid-April 2015.
Selective JAK1 inhibitor filgotinib has demonstrated a potential best-in-class profile in two 4-week Phase 2A trials in RA patients. Filgotinib is currently in a global Phase 2B program (DARWIN 1, 2 and 3) in 886 RA patients and in a Phase 2 trial in 180 patients with Crohn's disease.
DARWIN 1 is a 24 week double-blind, placebo-controlled trial that enrolled 599 patients with moderate to severe rheumatoid arthritis who inadequately responded to methotrexate; all patients remain on their background therapy of methotrexate. This trial evaluates three doses of filgotinib, as once- and twice-daily administration. In mid-April Galapagos expects to report topline results on the first 12 weeks of treatment, whereas the trial continues for an additional 12 weeks of treatment. Topline data from 24 weeks' treatment in DARWIN 1 is expected in July 2015.
Topline results from 12 weeks' treatment in DARWIN 1 will include unblinded ACR20 (primary endpoint) scores and other significant secondary endpoints, as well as important lab and safety information. Frequency of rare events, including severe adverse events, will be disclosed but will remain blinded until disclosure of the 24 week treatment topline data, 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," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "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."
About data management
Data management is a labor-intensive key step in clinical trials such as DARWIN. It is highly regulated since the data collected will be used for statistical analysis and report writing and will subsequently be subject to regulatory review. The data must reflect the medical records of the patients in the study, the source data as collected and stored at the study site. Therefore, the data collected on case report forms will be verified with the records in the hospitals, worldwide. All the data collected will be checked for missing, outlying or inconsistent values. When the data are complete and fully verified, the database is locked, such that data can no longer be changed. Only after this, the data analysis and statistical evaluation can start. This will finally lead to a set of analyzed data and a statistical analysis report.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 25 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. In the field of inflammation, AbbVie and Galapagos signed a collaboration agreement for the development and commercialization of filgotinib. Filgotinib is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2b studies in RA and in Phase 2 in Crohn's disease. GLPG1205, a first-in-class inhibitor of GPR84, is currently being tested in a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690 is a compound that targets pulmonary diseases and is currently in a Phase 1 trial. AbbVie and Galapagos also signed a collaboration agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
Galapagos forward-looking statements
This release may contain forward-looking statements, including, without limitation, statements concerning the safety and efficacy of filgotinib and the expected timing of the release of topline 12-week results from the DARWIN trials and the expected timing and announcement of topline 24-week results from the DARWIN trials, expectations regarding the commercial potential of our product candidates generally, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," "continues," "we believe," "we intend," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements and estimating the commercial potential of our product candidates. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.