Galapagos风湿性关节炎新药filgotinib临床二期研究获圆满成功

2015年4月15日讯/生物谷BIOON/--最近，来自比利时的生物医药公司Galapagos宣布，公司开发的口服JAK1抑制剂类药物filgotinib在最近的一项治疗风湿性关节炎的关键临床二期研究中取得了圆满成功。Filgotinib成功达到了研究人员设定的首要实验终点等目标。而就在几周前，国外媒体还曾对这一药物的研发过程做出期待称一旦这一药物的临床研究获得理想结果，Galapagos将可能是众多生物医药巨头争相收购的下一个香饽饽。
此次临床研究中，Galapagos主要测试了akaGLPG0634在治疗风湿性关节炎患者中的ACR20指标。经过12周的治疗，有80%的患者关节炎症状改善了20%以上，而这一现象在多个药物剂量组中都被观察到。这一数据也击败了其对照组药物methotrexate的治疗效果。此外，akaGLPG0634还完成了ACR50的次要实验目标。研究中还发现相当一部分患者在接受治疗的一周后就出现了病情改善的现象。此外，一些研究也表明filgotinib对其他的自身炎症疾病如克劳恩氏病也有良好的治疗作用。
这一喜讯也使得强生公司和艾伯维公司两大医药巨头心里乐开了花。其中前者是Galapagos公司的股东之一，后者在2012年就和Galapagos公司签订了关于合作研发filgotinib的协议，整个协议高达13.5亿美元之多。
不过，现在还不是Galapagos高兴的时候，因为filgotinib还并未达到遥遥领先的程度。就在不久前，礼来公司和Incyte公司开发的口服baricitinib的临床三期研究也获得了积极的研究数据。这也意味着未来在炎症疾病治疗领域又将掀起一场龙争虎斗。
详细英文报道：
BelgiumsGalapagos(Euronext:GLPG)saysthatitsoralJAK1inhibitorfilgotinibmetitsprimaryandotherendpointsinacrucialPhaseIIbstudyforrheumatoidarthritis.AnalystshavebeenkeepingaparticularlycloseeyeonthisdatadropsinceBloombergflaggedGalapagosafewweeksagoasapotentialtakeovertargetifthedataforthiswould-bebiologicssuccessorweregood.
InthesedaysofM&Afrenzyinbiopharma,itdoesnttakemuchtostokebuzzaboutpossiblebuyouts--orfirethembackup.
Todaysfreshtinder:Thedrug--akaGLPG0634--registeredimprovementsinACR20scores,withupto80%ofthepeopleinvariousdosinggroupsseeinga20%improvementindiseasesymptomsover12weeksofadd-ontherapytomethotrexate.TheprimaryendpointwasanimprovementinACR20scoresforadailydoseof200mgcomparedtoaplacebo.Atotalof594patientswhohadinadequateresponsetomethotrexatewererecruitedforthestudy.
GalapagosaddedthatstatisticallysignificantACR50scoreswerealsoachievedwithalldoselevelsanddoseregimens,seeingasignificantimprovementafteroneweek,indicatingrapidefficacyforsomepatients.
GoodnewsforGalapagosisalsogoodnewsatAbbVie($ABBV),whichpartneredonthedrug.FilgotinibisalsointheclinicforCrohnsdiseaseandhasapplicationsinotherinflammatoryconditions.Prespinout,AbbVieagreedtoa$1.35billiondealonthisdrugbackin2012:$150millionupfront,a$250millionpaymentforasuccessfulmidstageprogramand$1billionmoreinpromisedmilestones.
AsBloombergnoted,AbbVieandJohnson&Johnson($JNJ)arebothlosingblockbusterarthritisfranchises,andtheybothhaveastakeinGalapagos.J&Jownsapieceofthecompany.AndBryanGarnier&Co.isstokingthespeculationwithanestimatethattheneworalscomingthroughthepipelinecouldbeworthupto$27billion.ButGalapagosandAbbViearentaloneinthisfield,orahead.EliLilly($LLY)andIncyte($INCY)havebeenrackingupequallypositivePhaseIIIdatafortheoralbaricitinib,whichislikelytoheightenthesignificanceofthesafetydataforthesetherapies.
"ThelastdecadesawanimportantprogressinRAtreatmentwithbiologicals,"saidRenéWesthovensfromtheUniversityofLeuven,aprincipalinvestigatorforDARWIN1."Thecurrentdatawiththisoraldrugspellhopeforapotentialfuturetreatmentoptionthatcombinesfastonsetofactionandeaseofadministration.Iamparticularlyimpressedbytherapidimprovementreportedbythepatients.Alsotheincreaseinhemoglobinisimportantformypatients,asthismaylessenfatigueandenhancetheiroverallwell-being."
"Basedonthese12-weekresultsinRA,webelievethatfilgotinibhasapromisingfuturetoaddressasignificantmedicalneed.WelookforwardtoseeingtheDARWIN2monotherapyresultsinjustafewweeks,"saidDr.PietWigerinck,chiefscientificofficerofGalapagos.

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