- Five presentations demonstrate Galapagos' commitment to inflammation and the ulcerative colitis (UC) community
- New analyses will be presented from the SELECTION data set on prediction of response and remission, histology data and trajectory model
- Presentation on safety data of filgotinib in enriched risk population in rheumatoid arthritis
Dr
In addition to clinical data presentations, Galapagos is also hosting a hybrid symposium: ‘JAK to the future – a patient centric choice in UC’ on Monday
Scientific Abstracts:
Title | Authors | Presentation date/time |
Galapagos-driven abstracts | ||
Trajectory modelling to identify different types of individual response to therapy: a post hoc analysis from the SELECTION study | Poster Number: MP443 Date: Presentation time: 14:12 – 14:18 (6 min incl. 3 min discussion) Session: Response prediction in IBD - Moderated Poster | |
Predictors of response to filgotinib in ulcerative colitis: post hoc analysis from the SELECTION study | Poster Number: MP447 Date: Presentation time: 14:36 – 14:42 (6 min incl. 3 min discussion) Session: Response prediction in IBD - Moderated Poster | |
Use of faecal calprotectin as a prognostic marker of response to treatment with filgotinib: post hoc analysis from the SELECTION study | Poster Number: P0353 Date: Session: E-Poster Session - On-site poster round: | |
Assessment of histological remission in patients treated with filgotinib by different scores and concordance with endoscopic and health-related quality of life outcomes: post hoc analysis from the SELECTION study | Poster Number: P0488 Date: Session: E-Poster Session - On-site poster round: | |
Exploratory analysis of filgotinib safety data in a selected population of patients with rheumatoid arthritis: data from FINCH 1–4 and DARWIN 1–3 studies in perspective to integrated ulcerative colitis safety data | Poster Number: P0418 Date: Session: E-Poster Session - |
About ulcerative colitis
Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across
About the SELECTION study
The SELECTION Phase 3 study is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION study (NCT02914535) comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.
The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding sub-score of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a sub-score of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION study were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with UC. A majority of patients included in the SELECTION study (n=1348) had a Mayo Clinic Score (MCS) of 9 or higher at baseline, and 43% of biologic experienced patients (n=297/689) had insufficient response to a TNF antagonist and vedoluzimab as well. (Feagan et al.,
About filgotinib
Filgotinib is marketed as Jyseleca (200mg and 100mg tablets) in the
The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The Great Britain Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at www.emcmedicines.com/en-GB/northernireland, respectively. The interview form from the
Jyseleca® is a trademark of
About Galapagos
Galapagos is a fully integrated biotechnology company focused on discovering, developing, and commercializing innovative medicines. We are committed to improving patients’ lives worldwide by targeting diseases with high unmet needs. Our R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to Phase 4 programs in inflammation, oncology, fibrosis, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the
Contact
Investors:
Head of Investor Relations
+1 781 296 1143
Sandra Cauwenberghs
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
Media:
Marieke Vermeersch
Head of Corporate Communication
+32 479 490 603
media@glpg.com
Forward Looking Statements
This press release includes forward-looking statements, 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 “may,” “upcoming,” “future,” “potential,” “will,” and “plan,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding Galapagos’ plans and strategy with respect to Jyseleca and the DARWIN, SELECTION, and FINCH studies. Any forward-looking statements in this release are based on Galapagos management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results, performance or achievements to be materially different from any historic or future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with filgotinib may not be completed in the currently envisaged timelines or at all, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program and the DARWIN, SELECTION, and FINCH studies, the inherent risks and uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs, including but not limited to the data from the ongoing DARWIN, SELECTION, and FINCH studies, may not support registration or further development of filgotinib due to safety, efficacy or other reasons), the risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities, including EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, the risks that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future, Galapagos' reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead) and that Galapagos’ estimations regarding its filgotinib development program and regarding the commercial potential of filgotinib may be incorrect, the risk that Galapagos will not be able to continue to execute on its currently contemplated business plan and/or will need to revise its business plan, and risks related to the ongoing COVID-19 pandemic, as well as those risks and uncertainties identified in our most recent Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC), as supplemented and/or modified by any other filings and reports that we have made or will make with the
1 Burisch J. et al. Journal of Crohn’s and Colitis (2013); 7:322-337.
Attachment
- Galapagos provides further insights into the treatment of ulcerative colitis at the upcoming United European Gastroenterology (UEG) Week 2022 congress
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