Nine posters and four oral presentations reflect clinical progress toward triple combination therapy
Mechelen, Belgium; 27 October 2016 – Galapagos NV (Euronext & NASDAQ: GLPG) will present the following plenary presentations and posters at the North American Cystic Fibrosis Conference (NACFC) in Orlando this week:
Thursday 27 Oct. Oral session W02: CFTR 2016, 9:45 am ET
Bertrand Kleizen (Utrecht University) – “The novel potentiator GLPG1837 modulates CFTR through different mode of action than ivacaftor (Kalydeco®).”
Saturday 29 Oct . Oral session W22: Rare CFTR mutations & How to fix them, 10:30 am ET
Yi Cheng (RFUMS) – “The C.1766+1G->A splice site mutation causes Exon 13 skipping resulting in multiple defects in CFTR structure and function.”
Saturday 29 Oct. Oral session: W29: Emerging Strategies for Correcting the Basic CFTR Gene Defect, 10:30 am ET
Ashvani Singh (AbbVie) – “Discovery and Characterization of ABBV/GLPG2222, a novel first generation corrector.”
Mutyam Venkateshwar (UAB) – “Novel correctors and potentiators augment efficacy of translational readthrough in CFTR nonsense mutations.”
Poster 4 – The novel potentiator GLPG1837 modulates CFTR through different mode of action than ivacaftor (Kalydeco)
Galapagos reports on the investigation of mode of action of Kalydeco and GLPG1837 and determines when and where these potentiators work on the newly synthesized CFTR protein.
Poster 13 – The C.1766+1G->A splice site mutation causes Exon 13 skipping resulting in multiple defects in CFTR structure and function
RFUMS, Galapagos and AbbVie report the characterization of the C.1766+1G->A CFTR splice site mutation, showing it results in multiple defects including protein biogenesis, maturation and channel function.
Poster 19 – Measuring potentiator activity using organoids
Galapagos and AbbVie present the development of assays using patient-derived organoids and the data obtained using GLPG1837 across assays.
Poster 20 – Characterization of a novel potentiator series for treating cystic fibrosis
Galapagos and AbbVie describe the identification of a second generation potentiator series with very good channel opening activity. From this series, GLPG2451 was identified and is currently in Phase 1 clinical trials.
Poster 23 – Characterization of novel CFTR potentiators
University of Missouri-Columbia, Galapagos and Abbvie characterize potentiator GLPG1837 by patch clamp.
Poster 189 – Novel correctors and potentiators augment efficacy of translational readthrough in CFTR nonsense mutations
University of Alabama, Galapagos and AbbVie report the evaluation of combination(s) of novel correctors, a potentiator and Read Through agents to enhance efficacy in CFTR cells expressing a variety of nonsense mutations, to levels likely to be therapeutic for CF.
Poster 192 – Discovery and characterization of ABBV/GLPG2222, a novel first generation CFTR corrector
Galapagos and AbbVie report the identification and in vitro characterization of ABBV/GLPG2222, a novel, potent and orally bioavailable corrector currently in clinical trials that exhibits in vitro cellular improvements over the existing correctors in the clinic.
Poster 252 – Safety, tolerability and pharmacokinetics of a novel CFTR corrector molecule GLPG2222 in healthy volunteers
Galapagos and AbbVie report the results for the First-in-Human study with GLPG2222. Safety and tolerability were evaluated in oral single (up to 800 mg) and multiple ascending doses (up to 600 mg q.d. for 14 days) in healthy subjects. The pharmacokinetic profile showed GLPG2222 to be rapidly absorbed with an elimination half-life of 12 hours, steady-state after 2 days, and minimal accumulation. GLPG2222 was found to be generally well tolerated
Poster 253 – GLPG1837 in subjects with cystic fibrosis and the S1251N mutation: results from a phase2a study (SAPHIRA 2)
Novel potentiator GLPG1837 was administered in two doses, each for two weeks, to 7 patients with the S1251N mutation in a small, exploratory, open-label, multi-center study. Purpose of the study was to confirm in vitro observations with clinical responses. The doses selected for SAPHIRA 2 were at the low end of the efficacious dose range, whereby the exposures of GLPG1837 in plasma ranged around the lower target concentration for efficacy. Even at these low doses, CFTR activity was observed through decreases in sweat chloride and increases in FEV1, with changes in absolute percent predicted FEV1 from baseline in Kalydeco naïve patients being in line with those published for Kalydeco in S1251N subjects after two weeks treatment. A 7-day pre-treatment washout of Kalydeco impacted lung function slightly (-3%), and during treatment with GLPG1837, no further decline was observed in Kalydeco experienced patients. GLPG1837 was generally well tolerated in CF patients when dosed up to 4 weeks.
All posters will be made available on the Galapagos website, www.glpg.com, shortly following the presentation sessions. On Friday 28 October at 14.00 CET, there is a webcast and call on our Q3 Results. Our CSO Piet Wigerinck will be available to answer scientific questions.
The North American Cystic Fibrosis Conference is sponsored by the Cystic Fibrosis Foundation: www.cff.org
For more information on cystic fibrosis: http://www.glpg.com/rd-cystic-fibrosis
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 480 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
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This release may contain forward-looking statements, including statements regarding the potential activity of in the Company’s product candidates for cystic fibrosis. Forward-looking statements may 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 Galapagos’ ongoing clinical research programs in cystic fibrosis may not support registration or further development of its correctors and potentiators due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties (including the performance by AbbVie under the Galapagos-AbbVie Collaboration Agreement), and estimating the commercial potential of its 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.