COVID-19 Rufu: Chidzidzo Chitsva Chinoratidza 70% Kuderedza

RedHill Biopharma Ltd., kambani yakasarudzika biopharmaceutical, nhasi yazivisa mhedzisiro kubva kune mbiri ichangopedzwa yakatsanangurwa ongororo kubva kuoral opaganib (ABC294640) Chikamu chechipiri chekudzidza muchipatara chakanyanya COVID-2. Ongororo yekutanga yakaratidza kuti opaganib yakaderedza zvakanyanya kufa kana yakapihwa varwere vakagamuchira remdesivir uye corticosteroids, yakanakisa inowanikwa standard-yekutarisira (SoC) yevarwere vari muchipatara. Ongororo yechipiri yakaratidza zvakare kuti opaganib yakaunza bhenefiti yakakosha munguva yekupora, inotsanangurwa sekuwana mamakisi e3 kana zvishoma paWHO Ordinal Scale neZuva 19. Kambani iri kufambisira mberi nhaurirano dzekutonga munyika dzakawanda, ine mukana wekukurumidzira uye mvumo yekushambadzira. zvikumbiro zviri kurongerwa dzimwe nyika muhafu yekutanga ya1.    

Ongororo yakatemerwa yekufa kwevanhu, yakaitirwa varwere vese kubva muChidzidzo cheChikamu 2/3 vaigamuchira remdesivir uye corticosteroids pakutanga, yakaratidza kukosha kwe70.2% kufa kwevarwere vakarapwa opaganib, nehuwandu hwekufa hwe6.98% (n = 3/ 43) yeopaganib ruoko + SoC maringe ne23.4% (n=11/47) ye placebo + SoC neZuva 42 (p-value=0.034).

Yechipiri yakatsanangurwa ongororo yakaratidza opaganib yakaunza yakakosha 34% bhenefiti munguva yekupora, inotsanangurwa sekuwana mamakisi e1 kana zvishoma paWHO Ordinal Scale neZuva 14, ine 37.4% yevarwere vakarapwa opaganib (n = 86/230) kusvika pachiitiko ichi zvichienderana ne27.9% yevarwere (n = 65/233) vanobatwa ne placebo + SoC (p-value = 0.013, Hazard Ratio 1.49).

Kufambira mberi kwemutemo kuri kuramba kuchiitwa, nekupaganib data kutumira kwakatangwa muchikamu chechina cha2021 muUS, Europe, UK nedzimwe nyika. Nhaurirano dzinoramba dzichienderera mberi uye nhungamiro yekutanga pamusoro pechidzidzo chekusimbisa uye nzira inogona kubvumidzwa yakagamuchirwa kubva kuEU's EMA, US FDA, UK's MHRA nevamwe. Zvichienderana nemhinduro dzemitemo kubva kune dzimwe nzvimbo uye zano rekunze rakatambirwa, Kambani iri kurongawo zvikumbiro zvechimbichimbi uye zvemvumo yekushambadzira mune dzimwe nyika dzakadai muhafu yekutanga ya2022.

Oral opaganib yakadzidzwa mune yepasi rose Phase 2/3 yekudzidza muchipatara varwere vane yakanyanya COVID-19 pneumonia (NCT04467840). Mukuongororwa kwakatsanangurwa kwevose Phase 2/3 yekudzidza varwere vane PCR yakanaka pakuongorora opaganib vakavandudza nguva yepakati kusvika kuhutachiona hweRNA kubvumidzwa nemazuva angangoita 4, kuwana hutachiona hweRNA kubvumidzwa mukati memazuva gumi, nepo yepakati yekubvumidzwa yaive. isina kusvika pakupera kwemazuva gumi nemana kurapwa muruwoko rwe placebo (Hazard Ratio 10; nominal p-value=14, N=1.34/0.043). Pamusoro pezvo, mhedzisiro kubva kupost-hoc ongororo yedata kubva kune 437 vatori vechikamu muchidzidzo ichida Chikamu cheOkisijeni yakafuridzirwa (FiO463) kusvika uye kusanganisira 251% pakutanga (2% yevatori vechikamu) yakaratidza kuti kurapwa neoral opaganib kwakaguma ne60. % kudzikiswa kwekufa pamwe nekuvandudzwa kwemhedzisiro munguva yekuenda kumhepo, yepakati nguva yekuburitswa muchipatara, uye mukana wekupinda mukati uye mekiniki yekufema muboka hombe rechipatara, zvine mwero COVID-54 varwere.