Galapagos initiates second Phase I clinical trial for GLPG0259
(Thomson Reuters ONE) - * Following successful outcome of first-in-human trial* Addressing combination with existing standard treatment* Extended dosing in healthy volunteersMechelen, Belgium; 10 September 2009 - Galapagos NV (Euronext: GLPG)announced today that it has initiated a second Phase I clinical trialfor GLPG0259, a novel candidate drug being developed for rheumatoidarthritis (RA). The new trial is based on the positive outcome ofthe first-in-human trial conducted earlier in 2009, which showed agood safety profile in healthy volunteers and pharmacokinetics (PK)supporting once daily oral dosing. The trial is aimed at assessingthe combination of GLPG0259 with methotrexate (the current standardtreatment for RA), and at extending the treatment duration.Galapagos plans to conduct the multiple ascending dose study in 24healthy volunteers using three 14-day dosing regimens. The resultsof the study will aid in the design of a Phase IIa study planned for2010, where the efficacy of the novel candidate drug will be assessedin RA patients."We are pleased to progress our lead program based on our noveltarget discovery platform to this next step of clinical development,"stated Onno van de Stolpe, Galapagos' CEO. "This latest Phase I trialis designed to measure the longer term safety and tolerabilityprofile of GLPG0259, while also assessing any interactions with thecurrent standard treatment for RA. These results will provideinformation critical to the design of Phase II trials planned fornext year, where we will evaluate the candidate drug's efficacy intreating RA patients."About MAPKAPK5 and candidate drug GLPG0259Target MAPKAPK5 is a new starting point for the treatment ofrheumatoid arthritis (RA). Galapagos discovered and validated the keyrole of this target in the RA disease process, using its proprietarytarget discovery technology. MAPKAPK5 had not been previouslyassociated with RA; however, Galapagos showed that it plays a keyrole in inflammation and in the breakdown of collagen in humancartilage. The candidate drug GLPG0259 inhibits MAPKAPK5 in thehuman cell, and demonstrated excellent bone protection and reducedinflammation in a standard RA animal model.GLPG0259 is a novel mechanism-of-action inhibitor of the proteinkinase MAPKAPK5, which was discovered through Galapagos' targetdiscovery platform and represents a new approach for the treatment ofRA. It 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 up to 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 and Co. Through analliance with MorphoSys, Galapagos is also developing new antibodytherapies in bone and joint diseases. Its division BioFocus DPIoffers a full suite of target-to-drug discovery products and servicesto pharmaceutical 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: 10.09.2009 - 07:31 Uhr
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