Isivivinyo Esisha Somtholampilo Sezifo Ze-Celiac

A BAMBA Ukukhululwa Kwamahhala | eTurboNews | eTN
Ibhalwe ngu Linda Hohnholz

I-Immunic, Inc. namuhla imemezele ukuqala kweqembu lesiguli esivivinyweni sayo somtholampilo esiqhubekayo sesigaba soku-1 se-IMU-856, impahla yomtholampilo yesithathu yenkampani, ezigulini ezinesifo se-celiac.

I-IMU-856 iyimoduli encane ye-molecule etholakala ngomlomo futhi esebenza ngokuhlelekile eqondise isilawuli se-epigenetic esingadalulwanga. Ucwaningo lwe-preclinical luphakamisa ukuthi i-IMU-856 ingabuyisela ukusebenza kwesithiyo emgudwini wamathumbu futhi iphinde ivuselele ukwakheka kwamathumbu ngenkathi igcina i-immunocompetency. Ngokusekelwe kudatha yomtholampilo yangaphambi komtholampilo kanye neyokuqala etholakalayo kuze kube manje, inkampani ikholelwa ukuthi i-IMU-856 ingase imele inoveli kanye nendlela engase ibe nesisekelo ekwelapheni izifo zesisu.

"Ukuqala Kwengxenye C yalesi sigaba sokuhlolwa komtholampilo kwesigaba se-1 ezigulini zesifo se-celiac kubonisa ingqopha-mlando ebalulekile ekuthuthukisweni komtholampilo kwe-IMU-856, futhi sithemba ukuthi sizokwazi ukuqinisekisa amandla ayo okubuyisela ukusebenza kwesithiyo samathumbu ngaphandle kokuthinta amasosha omzimba," kusho uDaniel Vitt, Ph.D., Isikhulu Esiphethe kanye noMongameli we-Immunic. "Ngenxa yokuthi simele isidingo esibalulekile esingahlangatshezwana nezimpawu ezibonakala kahle zokuthatha indawo yesifo, sikholelwa ukuthi isifo se-celiac siyinkomba efanelekile yomtholampilo yokuhlinzeka ngobufakazi bomqondo womthelela onzima futhi ongapheli we-IMU-856. Indlela ye-IMU-856 ingase iveze indlela entsha ngokuphelele yokwelapha inani elibalulekile lezifo zesisu ezingathi sína nezivame kakhulu, futhi sikholelwa ukuthi inganikeza inzuzo yomtholampilo ngaphandle kwemiphumela engathi sína ehambisana nokwelashwa okuningi kokuzivikela komzimba. Ngaphezu kwalokho, sibheke ngabomvu ukuhlinzeka ngedatha egcwele yokuphepha esethwe ezingxenyeni zethamo elilodwa neziningi ezikhuphukayo zalesi sivivinyo somtholampilo esiqhubekayo sesigaba 1 ezifundweni zabantu abanempilo, okwamanje okulindeleke ukuthi zitholakale engxenyeni yesithathu yalo nyaka.”

“Isifo se-Celiac yisifo esihlala isikhathi eside futhi esibi kakhulu se-autoimmune ithumbu elincane i-pathophysiology yayo ibangelwa ukulimala okubangelwa i-gluten emgodleni wamathumbu. Naphezu kokunamathela ekudleni okungenalo i-gluten, iziguli eziningi zithola umsebenzi oqhubekayo wezifo ezingase zibangele isifo sohudo esingapheli, ubuhlungu besisu, ukubola kwezakhi zomzimba ngisho nokwandisa ingozi ye-anemia, i-osteoporosis kanye nomdlavuza othile, "kusho u-Andreas Muehler, MD, Isikhulu Esiphezulu Sezokwelapha. i-Immunic. "Kunesidingo esikhulu sokungenelela okuphumelelayo kwezokwelapha ezigulini ezinesifo se-celiac, njengoba okuwukuphela kwendlela yokwelapha namuhla ukudla okuqinile, okungapheli kwe-gluten, okuwumthwalo, okuvamise ukukhawulela umphakathi, futhi okuhluleka njalo ukumisa umsebenzi wesifo. . Ngenxa yamandla e-IMU-856 okubuyisela ukusebenza komgoqo wamathumbu kanye nokwakheka kwamathumbu, sikholelwa ukuthi le nhlanganisela inesithembiso esithile ekuthuthukiseni impilo yeziguli zesisu kanye nekhono lokugaya nokumunca kahle imisoco, ngaleyo ndlela yehlise imiphumela yesikhathi eside engenzeka futhi ithuthukise ikhwalithi yazo. impilo, izimpawu zezifo kanye nezinkinga ezingaba khona esikhathini esizayo.”

Izingxenye A kanye no-B zokuhlolwa okuqhubekayo komtholampilo kwesigaba 1 zihlola imithamo ekhuphukayo eyodwa neningi ye-IMU-856 ezifundweni zabantu ezinempilo. Ingxenye C manje eqalisiwe ihlelwe njengesivivinyo sezinsuku ezingama-28, esingaboni kabili, esilawulwa yi-placebo esiklanyelwe ukuhlola ukuphepha nokubekezelelana kwe-IMU-856 ezigulini ezinesifo se-celiac ngezikhathi zokudla okungenagluten kanye nenselele ye-gluten. Cishe iziguli ezingama-42 zihlelelwe ukubhaliswa emaqenjini amabili alandelanayo nge-IMU-856 enikezwa kanye ngosuku ezinsukwini ezingama-28. Izinjongo zesibili zihlanganisa i-pharmacokinetics kanye nezimpawu zezifo, kuhlanganise nalezo ezihlola ukwakheka kwamathumbu kanye nokuvuvukala. Cishe iziza eziyi-10 e-Australia naseNew Zealand okulindeleke ukuthi zibambe iqhaza kuNgxenye C.

Inkampani iphinda iphinda isiqondiso sayo sangaphambili sokuthi idatha yomugqa ophezulu wesigaba 2 se-vidofludimus calcium (IMU 838) ku-ulcerative colitis kulindeleke ukuthi itholakale ngoJuni ka-2022 kanye nokuthi idatha yokuqala yokusebenza komtholampilo yengxenye yeNgxenye C yesigaba sokuqala somtholampilo esiqhubekayo. ukuhlolwa kwe-IMU-1 ku-psoriasis kulindeleke engxenyeni yesibili ka-935.

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

  • Inkampani iphinda iphinda isiqondiso sayo sangaphambili sokuthi idatha yomugqa ophezulu wesigaba 2 se-vidofludimus calcium (IMU 838) ku-ulcerative colitis kulindeleke ukuthi itholakale ngoJuni ka-2022 kanye nokuthi idatha yokuqala yokusebenza komtholampilo yengxenye yeNgxenye C yesigaba sokuqala somtholampilo esiqhubekayo. ukuhlolwa kwe-IMU-1 ku-psoriasis kulindeleke engxenyeni yesibili ka-935.
  • “Start of Part C of this phase 1 clinical trial in celiac disease patients marks an important milestone in the clinical development of IMU-856, and we hope to be able to confirm its ability to restore intestinal barrier function without affecting the immune system,”.
  • The now initiated Part C is structured as a 28-day, double-blind, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge.

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Linda Hohnholz

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