- Global program to start in Q4'16
- DIVERSITY Phase 3 study in Crohn's disease
- SELECTION Phase 2b/3 study in ulcerative colitis
- 100 mg and 200 mg once daily doses included
MECHELEN, Belgium, Sept. 27, 2016 (GLOBE NEWSWIRE) -- Galapagos NV (Euronext & NASDAQ: GLPG) reports the successful
completion of discussions with the regulatory authorities in the US and Europe to initiate the DIVERSITY Phase 3 study in Crohn's
disease and the SELECTION Phase 2b/3 study in ulcerative colitis with filgotinib. Both studies will investigate efficacy and safety
of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderately to severely active disease including
those with prior antibody therapy failure. First dosing is expected in Q4'16.
Both studies will recruit approximately 1,300 patients each from the US, Europe, Latin America, Canada, and
Asia/Pacific. The SELECTION Phase 2b/3 study in ulcerative colitis will include a futility analysis, serving as the Phase 2b part
of this integrated Phase 2b/3 study. Men and women in both the SELECTION and DIVERSITY studies will be randomized to receive
placebo, 100 mg or 200 mg filgotinib. In the US, males may receive 200 mg if they failed at least one anti-TNF and
vedolizumab[1]. The filgotinib Phase 3 program will also contain a dedicated male patient testicular safety study.
"The outcome of the discussions with US and national European regulatory authorities enables our collaboration
partner Gilead to further evaluate filgotinib in IBD," said Dr Piet Wigerinck, Chief Scientific Officer at Galapagos. "The
improvements in clinical signs, quality of life, and endoscopy in Crohn's patients reported in the FITZROY Phase 2 study support
this next step."
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib
in inflammatory indications. Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016.
Filgotinib is an investigational therapy and its efficacy and safety have not been established.
For information about the studies with filgotinib in IBD: www.clinicaltrials.govFor more information about filgotinib: www.glpg.com/filgotinib
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of
small molecule medicines with novel modes of action. Our pipeline comprises a maturing pipeline of Phase 3, Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have
discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory
indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that
will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 460 employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn Fox |
VP IR & Corporate
Communications
+1 781 460 1784 |
Director Communications
+31 6 53 591 999
communications@glpg.com
|
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199 |
|
ir@glpg.com
|
|
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the
European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).
Forward-Looking Statements
This release may contain forward-looking statements, including statements regarding any guidance given by Galapagos'
management, the anticipated timing of clinical studies with filgotinib, the progression and results of such studies and ongoing
interactions with regulatory authorities. Galapagos cautions the reader that forward-looking statements are not guarantees of
future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause
the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be
materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed
or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and
liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may
not be predictive of results or developments in future periods. Among the factors that may result in differences are the inherent
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 in rheumatoid arthritis, Crohn's
disease and/or ulcerative colitis may not support registration or further development of filgotinib due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner for filgotinib,
Gilead), and estimating the commercial potential of Galapagos' product candidates. A further list and description of these risks,
uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports,
including in Galapagos' most recent annual report on form 20-F filed with the SEC and subsequent filings and reports filed
by Galapagos with the SEC. 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 or that may affect
the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required
by law or regulation.
[1] Vedolizumab is a monoclonal anti-integrin antibody developed by Millennium Pharmaceuticals.
Succesful completion of regulatory discussions filgotinib in IBD http://hugin.info/133350/R/2045017/763762.pdf