Olamkicept tau muaj kev vam meej hauv kev kho mob ntawm ulcerative colitis (UC) theem 2 kev sim tshuaj!

I-mab Biopharma (Shanghai) Co., Ltd. (I-mab Biopharma, tom qab no hu ua "TJB") tsis ntev los no tau tshaj tawm cov tshuaj ntsuam xyuas los ntawm olamkicept (sgp130Fc, tseem hu ua TJ301) rau kev kho mob ntawm active ulcerative colitis (UC) Muaj qhov tshwm sim zoo saum toj kawg los ntawm ntu 2 kev tshawb fawb (NCT03235752). Qhov no yog lub regional multicenter, randomized, dig muag ob, qhov chaw kawm tshuaj uas tau soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm kev tso ntshav qab zib ntawm olamkicept ob zaug ib lub lim tiam hauv kev kho mob ntawm cov neeg mob uas nquag UC.

Olamkicept (TJ301) tsuas yog xaiv cov IL-6 inhibitor nyob rau hauv kev kho mob theem uas ua haujlwm dhau los ntawm kev siv cov trans-signaling mechanism. IL-6 yog qhov tseem ceeb tsav rau kev sib kis thiab kev saib xyuas ntawm tus mob mus ntev ntawm cov kab mob autoimmune (xws li UC).

Kev kawm qib 2 no yog ib qho ntawm cov thawj tso tshuaj, pov thawj ntawm kev tshawb fawb ntawm IL-6 inhibitors hauv UC. Txoj kev tshawb no tau mus txog qhov kawg ntawm qhov pib thiab qhov tseem ceeb theem ob kawg: (1) Tom qab 12 lub lis piam ntawm kev kho mob, nrog cov placebo piv nrog cov tshuaj pab pawg, 600mg koob tshuaj olamkicept pawg pom pom muaj ntau dua cov lus teb tau zoo sib luag (p=0.032); (2) Piv nrog cov pab pawg placebo, 600mg koob olamkicept pawg tau muaj ntau dua qhov feem ntau ntawm cov neeg mob ua tiav kev kho mob thiab kev kho mob mucosal (p< 0.001),="" uas="" yog="" ob="" qhov="" tseem="" ceeb="" hauv="" qab="" kawg="" ntawm="" txoj="" kev="" tshawb="" no.="" (3)="" olamkicept="" muaj="" kev="" tiv="" thaiv="" zoo="" thiab="" tau="" txais="" kev="" nyab="" xeeb="">

Cov ntaub ntawv ntxaws ntxaws ntxaws ntawm qhov kev tshawb fawb yuav tshaj tawm ntawm US Digestive Disease Week (DDW) thaum Lub Tsib Hlis 2021 thiab European Crohn's Disease and Colitis Organization (ECCO) lub rooj sib tham thaum Lub Xya Hli 2021.

Tus xibfwb Chen Minhu uas yog tus kws tshawb fawb txog kev tshawbfawb, thawj saibxyuas ntawm thawj lub Tsev Khomob Tsev Kawm Qib Siab hauv Sun Yat-sen University, thiab tus kws khomob ntawm Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv, hais tias: "Peb zoo siab pom tias dhau ntawm ntu ua tiav no 2 kev kawm, olamkicept tsom lub ntsiab lus ntawm kev nyab xeeb thiab ua haujlwm. Cov neeg mob uas ua haujlwm nrog UC tau pom tias muaj txiaj ntsig zoo rau kev kho mob. Nov yog thawj zaug ua qauv qhia tias thaiv IL-6 los ntawm cov kev qhia hla kev ua si ua lub luag haujlwm tseem ceeb hauv UC. Txoj kev tshawb no yog txhawm rau kev txhim kho kev saib xyuas txuas ntxiv ntawm qhov sib txawv ntawm IL-6 kev thaiv. Hydrating cov neeg sawv cev muab kev ntseeg siab uas yog txoj kev kho mob rau UC thiab mob hnyuv (IBD)."

Dr. Shen Huaqiong, CEO ntawm Tianjing Biotech, tau hais tias: "Vim tias kev kho tshuaj tam sim no muaj cov kev mob tshwm sim loj heev thiab yuav muaj qhov tsis kam thaum lub sijhawm dhau los, kev kho cov mob plab hnyuv (xws li UC) tsis txaus siab. Cov Txheej Txheem Zoo Theem 2 txhawb nqa peb txoj kev ntseeg tias olamkicept muaj peev xwm dhau los ua tus qauv kev kho mob rau UC, thiab peb zoo siab txog kev cia siab ntawm kev tshawb nrhiav qhov dav dav thoob ntiaj teb tus neeg mob thiab muab txoj hauv kev kho mob tshiab."

Thaum Lub Kaum Ib Hlis 2016, Horizon Biotech tau kos npe pom zoo nrog Ferring Pharmaceuticals kom tau txais daim ntawv tso cai tshwj xeeb los tsim kho thiab ua lag luam olamkicept hauv Greater Tuam Tshoj thiab Kaus Lim Qab Teb. Thaum Lub Plaub Hlis 23, 2021, ob tog tau kos npe rau M Mem Kev Tshawb Fawb (MoU) los tshawb txog txoj kev koom tes hauv kev txhim kho thiab kev ua lag luam ntawm olamkicept hauv Tebchaws Meskas, Canada, European thiab Nyij Pooj.

Olamkicept yog ib homodimer ntawm fusion protein uas muaj cov txheej txheem ntxiv ntawm tib neeg glycoprotein 130 (gp130) thiab cov crystallizable fragment (Fc) ntawm tib neeg IgG1. Olamkicept suav nrog ob thaj tsam ntawm gp130, thiab dimerized los ntawm Fc ib feem ntawm tib neeg IgG1, uas tuaj yeem ntes cov ua haujlwm ntawm IL-6 thiab soluble IL-6 receptor (IL-6R).

Olamkicept yog tib txoj kev xaiv qhov tsis haum ntawm IL6 trans-signaling pathway hauv kev kho mob hauv theem. Piv nrog rau lwm cov tshuaj pom zoo IL-6 lossis IL-6R tshuaj tiv thaiv kab mob, olamkicept muaj kev nyab xeeb zoo dua vim tias nws tsis cuam tshuam rau lub cev kev ua haujlwm ntawm IL-6, xws li kev tiv thaiv kab mob rau hauv kev tiv thaiv kab mob thiab kev cai metabolic.

Olamkicept muaj lub peev xwm los ua cov tshuaj zoo tshaj plaws rau kev kho mob ntawm cov kab mob autoimmune uas hauv UC thiab lwm yam IL-6 yog qhov tseem ceeb ntawm cov neeg kho kom haum xeeb. Tam sim no, thawj qhov ntsuas tau tsim los ntawm Tianjing Bio rau olamkicept yog UC, thiab lub tuam txhab kuj npaj los tsim lwm yam kev qhia rau IL-6-mediated o.