Matenda a Chiwindi B: Mayesero Atsopano Achipatala

Brii Biosciences Limited, kampani yapadziko lonse lapansi yomwe ikupanga njira zatsopano zochiritsira matenda omwe ali ndi zosoweka zachipatala zosakwaniritsidwa komanso zovuta zazikulu zaumoyo wa anthu, yapereka wodwala woyamba muyeso lachipatala la Phase 2a/2b la BRII-179 (VBI-2601) mwa odwala omwe ali ndi vuto lachipatala. matenda a chiwindi B (HBV). Pafupifupi anthu 290 miliyoni padziko lonse lapansi akukhala ndi matenda osachiritsika a HBV, ndipo pafupifupi anthu 800,000 amamwalira chaka chilichonse chifukwa cha zovuta monga matenda okhudzana ndi HBV, kulephera kwa chiwindi, ndi khansa zina.           

"BRII-179 imatha kusokoneza kulolerana kwa chitetezo chamthupi ndikubwezeretsanso kapena kukulitsa ma T cell ndi mayankho a antibody ku ma antigen a HBV. Izi zitha kukhazikitsa kuyankha kwa chitetezo chamthupi ku HBV ndikupanga mwayi wopeza chithandizo chamankhwala osatha a HBV, "atero Li Yan, MD, Ph.D., wamkulu wachipatala ku Brii Bio. "Odwala matenda a HBV osatha pakadali pano amangopeza chithandizo chomwe chimapangitsa kuti anthu azikhala ndi nambala imodzi yokha yochizira. Tikuyembekeza kugwira ntchito limodzi ndi ofufuza athu ku China kuti tidziwe chitetezo ndi zotsatira za BRII-179 polimbikitsanso chitetezo chamthupi cha HBV pagulu la odwalawa, zomwe zitha kumasulira kukhala machiritso apamwamba kwambiri. "

BRII-179 (VBI-2601) ndi buku lophatikizanso, lopangidwa ndi mapuloteni a HBV immunotherapeutic candidate lomwe limafotokoza ma antigen a Pre-S1, Pre-S2, ndi S HBV, ndipo adapangidwa kuti apangitse chitetezo chokwanira cha B-cell ndi T-cell. . BRII-179 (VBI-2601) imamanga pa 3-antigen conformation ya VBI Vaccines' prophylactic HBV vaccine, yomwe imavomerezedwa ku US pansi pa dzina la PreHevbrio™ [Katemera wa Hepatitis B (Recombinant)].

Mayesero a Gawo 2 awa a BRII-179 ndi kafukufuku wapawiri, wosasinthika, woyendetsedwa ndi placebo, gulu lofanana kuti awone zotsatira zachipatala zowonjezera BRII-179 (VBI-2601) ku PEG-IFN-α ndi nucleos (t). ) Ide reverse transcriptase inhibitor (NrtI) yodziwika bwino yothandizira odwala omwe ali ndi HBV osadwala matenda a cirrhotic. Odwala omwe akutenga nawo mbali mu phunziroli adakumana ndi zomwe zafotokozedwa kale za mayankho ang'onoang'ono ku chithandizo chopitilira PEG-IFN-α ndi NrtI. Bungwe lodziyimira palokha la Data and Safety Monitoring Board lidzayang'anira chitetezo cha odwala komanso momwe chithandizo chamankhwala chikuyendera pa kafukufukuyu.

Gawo 2a:

• Gawo la 2a gawo la phunziroli lidzatsimikizira mphamvu ndi chitetezo cha mankhwala a BRII-179 (VBI-2601) pafupifupi odwala 120 kuphatikizapo PEG-IFN-α + Nrtl therapy.

• Mapeto oyambirira a Phase 2a ndi chiwerengero cha odwala omwe ali ndi vuto la HBsAg pakutha kwa chithandizo.

Gawo 2b:

• Mu Gawo 2b, phunziroli lidzakula kwa odwala 480 kuti aone kuchuluka kwa odwala omwe akupeza chithandizo chamankhwala atalandira chithandizo cha BRII-179 (VBI-2601) pamodzi ndi PEG-IFN-α + NrtI.

• Mapeto oyambirira a Phase 2b ndi chiwerengero cha odwala omwe akupeza kutayika kwa HBsAg ndi HBV DNA.