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Novartis's First Complement Factor B Inhibitor Iptacopan Ua Tau Zoo hauv Kev Kho C3 Glomerulopathy (C3G)!

[Nov 27, 2021]

Novartis tsis ntev los no tau tshaj tawm tias theem 2 kev tshawb fawb soj ntsuam (NCT03832114) ntsuas thawj qhov ncauj xaiv qhov tseem ceeb B inhibitor iptacopan (LNP023) rau kev kho mob ntawm cov neeg mob C3 glomerulopathy (C3G) mus txog qhov kawg ntawm ob tus neeg mob cohorts. Cov ntaub ntawv no yuav raug tso tawm ntawm 2021 lub rooj sib tham txhua xyoo ntawm American Society of Nephrology (ASN).


C3G yog ib qho tsis tshua muaj thiab hnyav thawj glomerulonephritis, uas yog tus cwj pwm los ntawm kev tsis sib haum xeeb ntawm kev tswj hwm. Qhov tshwm sim txhua xyoo ntawm tus kab mob thoob ntiaj teb yog 1-2 feem ntawm ib lab. Muaj li ntawm 10,000 tus neeg mob hauv Tebchaws Meskas, kwv yees li 10,500 tus neeg mob hauv Tebchaws Europe, kwv yees li 3,200 tus neeg mob hauv Nyij Pooj, thiab txog 32,000 tus neeg mob hauv Suav teb. C3G feem ntau kuaj tau rau cov hluas thiab cov hluas. Qhov kev cia siab ntawm tus kab mob yog qhov tsis zoo. Kwv yees li 50% ntawm cov neeg mob tsim cov kab mob hauv lub raum kawg (ESRD) hauv 10 xyoo, thiab 50-70% ntawm cov neeg mob rov ua dua tom qab hloov lub raum.


Iptacopan yog thawj qhov ncauj qhov ncauj B inhibitor nrhiav tau los ntawm Novartis Lub Tsev Haujlwm ntawm Kev Tshawb Fawb Biomedical. Factor B yog ib qho tseem ceeb ntawm serine protease nyob rau hauv lwm txoj hauv kev ntawm kev ua kom tiav. Iptacopan muaj peev xwm los ua thawj lub hom phiaj kho kom ncua kev nce qib ntawm C3G lim ntshav. Thaum Lub Kaum Hli 2021, British Tshuaj thiab Cov Khoom Siv Khomob Tswjhwm Saib Xyuas Kev Noj Qab Haus Huv (MHRA), National Institute of Health thiab Clinical Optimization (NICE), thiab Scottish Medical Federation (SMC) tau koom ua ke muab iptacopan rau" Innovation Passport" rau kev kho mob ntawm C3G." kev tsim nyog.


ASN lub rooj sib tham txhua xyoo tau tshaj tawm yog qhib-daim ntawv lo, 2 pawg, tsis yog randomized Theem 2 txoj kev tshawb fawb, uas yog lub hom phiaj los ntsuas iptacopan' kev kho mob ntawm C3G cov neeg mob uas tseem tsis tau hloov lub raum (cohort A) thiab leej twg. tau txais kev hloov hauv lub raum thiab tom qab ntawd hloov cov khoom nruab nrog cev. Kev ua tau zoo, kev nyab xeeb, thiab cov tshuaj pharmacokinetics ntawm cov neeg mob C3G rov ua dua (Cohort B). Hauv txoj kev tshawb no, ntxiv rau kev tau txais kev kho keeb kwm yav dhau, cov neeg mob kuj tau txais qhov ncauj iptacopan (200 mg, ob zaug ib hnub) rau 12 lub lis piam. Thawj qhov kawg ntawm pawg A yog qhov txo qis hauv cov proteinuria ( ntsuas los ntawm UPCR 24h) los ntawm lub hauv paus mus rau 12 lub lis piam ntawm kev kho mob. Thawj qhov kawg ntawm pawg B yog qhov hloov pauv los ntawm lub hauv paus mus rau 12 lub lim tiam ntawm lub raum biopsy C3 deposition qhab nia (raws li immunofluorescence microscopy). Tom qab txoj kev tshawb fawb tiav lawm, txhua tus neeg mob tuaj yeem xaiv tau txais kev kho mob iptacopan txuas ntxiv hauv txoj kev tshawb fawb mus sij hawm ntev (NCT03955445).


Qhov kev ntsuam xyuas zaum kawg tau pom tias: (1) Hauv cov neeg mob hauv pawg A (n=16), proteinuria tau txo qis los ntawm 45% los ntawm qhov pib ntawm 12 lub lis piam ntawm kev kho mob ( ntsuas los ntawm UPCR 24h, p=0.0003); (2) hauv cov neeg mob hauv pawg B (Nyob rau hauv n=7), ntawm 12 lub lis piam ntawm kev kho mob, C3 protein deposition tau txo qis los ntawm cov hauv paus ( ntsuas los ntawm lub raum biopsy C3 qhab nia, p=0.0313). (Ceeb toom: 11 tus neeg mob tau tso npe rau hauv pawg B, tab sis tsuas yog 7 tus neeg mob muaj cov ntaub ntawv los txheeb xyuas qhov kawg ntawm C3 protein deposition)


Tsis tas li ntawd, ob pawg pab pawg tau pom muaj zog thiab txuas ntxiv inhibition ntawm kev hloov pauv txoj hauv kev ua haujlwm thiab normalization ntawm qib C3 hauv 12 lub lis piam ntawm kev kho mob. Hauv cov ntaub ntawv sib sau ua ke ntawm ob pawg, raws li kev ntsuas los ntawm kwv yees glomerular filtration rate (eGFR), lub raum kev ua haujlwm tseem nyob ruaj khov tom qab 12 lub lis piam (qhov nruab nrab nce ntawm 1.04 mL / min piv rau cov hauv paus ntsiab lus). Cov ntaub ntawv los ntawm yav dhau los xa mus rau qhov kev tshawb fawb txuas ntxiv mus ntev (NCT03955445) tau pom tias lub raum ua haujlwm ntawm 7 cov neeg mob uas tau kho rau 6 lub hlis tau khaws cia nyob rau lub sijhawm ntawd, qhia tias kev kho iptacopan txuas ntxiv tuaj yeem ncua lossis tiv thaiv qhov tshwm sim ntawm lub raum tsis ua haujlwm.


Nyob rau hauv qhov kev ntsuam xyuas zaum kawg, iptacopan tau pom tias muaj kev nyab xeeb zoo thiab kev zam txim, thiab tsis muaj cov xwm txheej tsis zoo uas xav tias muaj feem xyuam nrog iptacopan.


Edwin Wong, tus kws kho mob nephrologist ntawm Newcastle University hauv tebchaws United Kingdom, tus thawj coj tshawb fawb ntawm txoj kev tshawb no, tau hais tias:" Cov ntaub ntawv tshaj tawm ntawm ASN lub rooj sib tham txhua xyoo tau piav qhia txog lub peev xwm ntawm iptacopan rau kev kho mob ntawm C3G cov neeg mob thiab lub peev xwm rau Kev kho mob ntawm cov neeg mob C3G rov qab los tom qab hloov lub raum. Cov txiaj ntsig no yog cov txiaj ntsig no. Nws yog ib qho tseem ceeb rau cov neeg mob C3G, vim hais tias proteinuria yog ib qho tseem ceeb ntawm kev pheej hmoo rau kev loj hlob ntawm cov kab mob hauv lub raum, thiab qhov tso tawm ntawm cov protein C3 yuav kawg ua rau mob thiab lub raum puas."


John Tsai, tus thawj coj ntawm kev txhim kho tshuaj thoob ntiaj teb thiab tus thawj coj saib xyuas kev noj qab haus huv ntawm Novartis Pharmaceuticals, tau hais tias: "C3G yog ib qho kab mob loj heev. Cov neeg mob zaum kawg yuav ntsib lub raum dialysis lossis hloov lub raum. Txij li tam sim no tsis muaj kev pom zoo kho mob, nws tuaj yeem ncua lub raum ua haujlwm. Muaj cov kev xav tau kev kho mob tseem ceeb rau kev kho mob ntawm kev ua tsis tiav. Cov ntaub ntawv no qhia tau hais tias iptacopan tuaj yeem muaj zog thiab tshwj xeeb inhibit qhov tseem ceeb ntawm kev tsav tsheb ntawm C3G-txoj kev lwm txoj hauv kev ntxiv. Cov txiaj ntsig tseem qhia tau tias iptacopan muaj peev xwm muab thawj C3G cov neeg mob Rau kev kho mob, peb tab tom nrhiav cov neeg mob los koom rau hauv qhov tseem ceeb Theem 3 appEAR-C3G kev tshawb fawb."

iptacopan

iptacopan cov qauv tshuaj


iptacopan yog thawj-hauv-chav kawm, qhov ncauj, muaj zog, xaiv, me me molecule, thiab thim rov qab yam B inhibitor. Factor B yog ib qho tseem ceeb ntawm serine protease nyob rau hauv lwm txoj hauv kev ntawm kev ua kom tiav.


Tam sim no, iptacopan tab tom tsim los kho ntau yam kab mob ntxiv rau lub raum (CDRD) nrog cov kev xav tau kev kho mob tseem ceeb, suav nrog C3G, IgA nephropathy, atypical hemolytic uremic syndrome (aHUS), membranous nephropathy (MN) ), thiab cov kab mob tsis tshua muaj ntshav paroxysmal. nocturnal hemoglobinuria (PNH).


Cov ntaub ntawv luam tawm Theem 2 tau pom tias: (1) kev kho mob ntawm IgAN nrog iptacopan txo cov proteinuria thiab stabilized raum ua haujlwm; (2) Kev kho mob ntawm C3G txo qis qis ntawm kwv yees glomerular filtration rate (eGFR) thiab stabilized raum ua haujlwm; (3) Kev kho mob ntawm PNH ua rau txo qis intravascular thiab extravascular hemolysis, ua rau cov neeg mob feem ntau ua tiav kev txhim kho sai thiab ntev ntev yam tsis muaj ntshav.


Txawm hais tias Novartis muaj 35 xyoo keeb kwm hauv kev kho mob raum hloov pauv, iptacopan yog thawj qhov kev kho mob rau CDRD hauv cov kab mob raum. Novartis lub hom phiaj yog los hloov txoj hauv kev kho mob los ntawm kev tsom mus rau ib qho ntawm cov tsav tsheb tseem ceeb ntawm cov kab mob uas tsis tshua muaj thiab muaj kev vam meej, uas muaj peev xwm txuas ntxiv lub neej uas tsis yog kev lim ntshav ntawm CDRD.