ʻO ka maʻi Hepatitis B: ʻO ka hoʻāʻo hou

ʻO Brii Biosciences Limited, kahi hui lehulehu e hoʻomohala ana i nā lāʻau lapaʻau hou no nā maʻi me nā pono olakino koʻikoʻi a me nā kaumaha nui o ke olakino lehulehu, ua kau ʻo ia i ka mea maʻi mua i kahi hoʻokolohua lapaʻau Phase 2a/2b no BRII-179 (VBI-2601) i nā maʻi me ʻo ka maʻi hepatitis B mau loa (HBV). Ma kahi o 290 miliona mau kānaka ma ka honua holoʻokoʻa e noho nei me ka maʻi HBV mau loa, a kokoke i ka 800,000 poʻe e make i kēlā me kēia makahiki mai nā pilikia e like me ka cirrhosis pili i ka HBV, ka hāʻule ʻole o ka ate, a me nā maʻi maʻi e pili ana.           

"Loaʻa i ka BRII-179 ka hiki ke uhaʻi i ka pale ʻana a hoʻihoʻi a hoʻonui paha i ka adaptive T cell a me nā pane antibody i nā antigens surface HBV. ʻO kēia ka mea e hoʻokumu ai i kahi pane pale pale paʻa i ka HBV a hana i ka hiki ke loaʻa kahi lāʻau lapaʻau no ka maʻi maʻi HBV mau, "wahi a Li Yan, MD, Ph.D., ka luna lapaʻau nui ma Brii Bio. "ʻO nā maʻi maʻi HBV maʻi i kēia manawa ke loaʻa wale i nā lāʻau lapaʻau e hopena i ka helu hoʻōla hana hoʻokahi. Manaʻo mākou e hana pū me kā mākou mau mea noiʻi ma Kina e hoʻoholo i ka palekana a me ka hopena o BRII-179 i ka hoʻolaʻa hou ʻana i ka HBV-specific adaptive immune function i kēia heluna maʻi, hiki ke unuhi ʻia i kahi helu hoʻōla ʻoi aku ka nui.

ʻO BRII-179 (VBI-2601) he moho hou hou, hoʻokumu ʻia i ka protein HBV immunotherapeutic moho e hōʻike ana i ka Pre-S1, Pre-S2, a me S HBV surface antigens, a ua hoʻolālā ʻia e hoʻoikaika i ka pale B-cell a me T-cell immunity. . Kūkulu ʻia ʻo BRII-179 (VBI-2601) ma luna o ka 3-antigen conformation o ka VBI Vaccines 'prophylactic HBV vaccines, i ʻae ʻia ma US ma lalo o ka inoa PreHevbrio™ [Hepatitis B Vaccine (Recombinant)].

ʻO kēia hoʻokolohua Phase 2 o BRII-179 he papalua-makapō, randomized, placebo-controlled, parallel-group study e loiloi i ka hopena o ka hoʻohui ʻana iā BRII-179 (VBI-2601) i ka PEG-IFN-α a me nā nucleos (t) )ide reverse transcriptase inhibitor (NrtI) standard-of-care therapy i nā maʻi HBV mau ʻole cirrhotic. ʻO nā poʻe maʻi e komo ana i ke aʻo ʻana ua hoʻokō i nā pae hoʻohālike i wehewehe mua ʻia no nā pane ʻāpana i ka mālama ʻana i ka PEG-IFN-α a me NrtI. E nānā ka Papa Hoʻonaʻauao Kūʻokoʻa i ka palekana o ka maʻi a me ka maikaʻi o ka mālama ʻana no kēia haʻawina.

Māhele 2a:

• ʻO ka māhele Phase 2a o ka haʻawina e hoʻoholo i ka pono a me ka palekana o ka lāʻau BRII-179 (VBI-2601) ma kahi o 120 mau maʻi i hui pū me ka PEG-IFN-α + Nrtl therapy.

• ʻO ka hopena mua o ka Phase 2a ka pākēneka o nā maʻi me ka HBsAg nalowale i ka pau ʻana o ka mālama ʻana.

Māhele 2b:

• Ma ka Phase 2b, e hoʻonui ka haʻawina i nā maʻi 480 e loiloi i ka hapa o nā maʻi e loaʻa ana ka lāʻau lapaʻau ma hope o ka loaʻa ʻana o BRII-179 (VBI-2601) i hui pū me PEG-IFN-α + NrtI.

• ʻO ka hopena mua o ka Māhele 2b ka pākēneka o nā maʻi i loaʻa i ka HBsAg a me ka HBV DNA nalowale.