Galapagos successfully completes first Phase I study for GLPG0259
(Thomson Reuters ONE) - * Clinical results demonstrate safety in man* Pharmacokinetic profile supports once-daily oral dosingMechelen, Belgium; 6 August 2009 - Galapagos NV (Euronext: GLPG)announces the successful completion its first-in-human trial of thenovel candidate drug GLPG0259 for rheumatoid arthritis (RA). Thecandidate drug showed good safety in healthy volunteers and anexcellent pharmacokinetic (PK) profile thus far, which supportsonce-daily oral dosing. GLPG0259 is a novel mechanism-of-actioninhibitor of the protein kinase MAPKAPK5, which was discoveredthrough Galapagos' target discovery platform and represents a newapproach for the treatment of RA.The goal of the first-in-human trial was to determine the safety,tolerability, and pharmacokinetics of the candidate drug GLPG0259.The double blind, single ascending and multiple dose study wasconducted in 34 healthy volunteers in Belgium from March to May2009. The compound was administered up to five consecutive days andshowed good safety, with no cardiovascular side effects. The desiredPK profile obtained thus far supports once-daily oral dosing."We are encouraged by the positive outcome of the first human trialfor a candidate drug derived from Galapagos' target discoveryplatform," said Onno van de Stolpe, CEO of Galapagos. "We are ontrack to complete the Phase I trials for GLPG0259 by the end of2009. Furthermore, preparations are underway to start a Phase IIastudy in 2010, where we will assess the efficacy of this novelmechanism of action candidate drug in treating RA patients."About MAPKAPK5 and candidate drug GLPG0259Target MAPKAPK5 is a new starting point for the treatment of RA.Galapagos discovered and validated the key role of this target in theRA disease process, using its proprietary target discoverytechnology. MAPKAPK5 had not been previously associated with RA;however, Galapagos showed that it plays a key role in inflammationand in the breakdown of collagen in human cartilage. The candidatedrug GLPG0259 inhibits MAPKAPK5 in the human cell, and demonstratedexcellent bone protection and reduced inflammation in a standard RAanimal model.GLPG0259 is a compound in Galapagos' internal RA program, which ispart of an option agreement with Janssen Pharmaceutica. Upon thecompletion of a dose finding Phase II clinical trial for GLPG0259,Janssen has the exclusive option to license the program for ?60million, with further potential milestones to Galapagos of ?776million and double-digit royalties on global sales.About GalapagosGalapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery anddevelopment company with small molecule programs in bone and jointdiseases, bone metastasis, cachexia, anti-infectives and metabolicdiseases. It has established risk sharing alliances with GSK,Janssen Pharmaceutica, Eli Lilly and Merck. Through an alliance withMorphoSys, Galapagos is also developing new antibody therapies inbone and joint diseases. Its division BioFocus DPI offers a fullsuite of target-to-drug discovery products and services topharmaceutical and biotech companies and to patient foundations,encompassing target discovery and validation, screening and drugdiscovery through to delivery of pre-clinical candidates. Galapagoscurrently employs 495 people and operates facilities in sixcountries, with global headquarters in Mechelen, Belgium. More infoat: www.glpg.com.CONTACTGalapagos NVOnno van de Stolpe, CEOTel: +31 6 2909 8028ir(at)glpg.comThis release may contain forward-looking statements, including,without limitation, statements containing the words "believes,""anticipates," "expects," "intends," "plans," "seeks," "estimates,""may," "will," "could," "stands to," and "continues," as well assimilar expressions. Such forward-looking statements may involveknown and unknown risks, uncertainties and other factors which mightcause the actual results, financial condition, performance orachievements of Galapagos, or industry results, to be materiallydifferent from any historic or future results, financial conditions,performance or achievements expressed or implied by suchforward-looking statements. Given these uncertainties, the reader isadvised not to place any undue reliance on such forward-lookingstatements. These forward-looking statements speak only as of thedate of publication of this document. Galapagos expressly disclaimsany obligation to update any such forward-looking statements in thisdocument to reflect any change in its expectations with regardthereto or any change in events, conditions or circumstances on whichany such statement is based, unless required by law or regulation.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 06.08.2009 - 07:31 Uhr
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