Ciwon Hanta na Jiki na B: Sabuwar Gwajin Asibiti

Brii Biosciences Limited, wani kamfani na kasa-da-kasa da ke haɓaka sabbin hanyoyin kwantar da hankali don cututtuka tare da manyan buƙatun likita marasa cikawa da manyan nauyin lafiyar jama'a, ya ƙaddamar da mara lafiya na farko a cikin gwaji na asibiti na Phase 2a/2b don BRII-179 (VBI-2601) a cikin marasa lafiya tare da na kullum hepatitis B virus (HBV). Kimanin mutane miliyan 290 a duk duniya suna rayuwa tare da kamuwa da cutar HBV na yau da kullun, kuma kusan mutane 800,000 ne ke mutuwa kowace shekara daga rikice-rikice irin su cirrhosis masu alaƙa da HBV, gazawar hanta, da cututtukan daji masu alaƙa.           

"BRII-179 yana da yuwuwar karya juriya na rigakafi da dawo da ko haɓaka tantanin halitta T mai daidaitawa da martanin antibody zuwa antigens na HBV. Wannan zai samar da martani mai ɗorewa ga HBV kuma ya haifar da yuwuwar samun magani na aiki don kamuwa da cutar ta HBV na yau da kullun, "in ji Li Yan, MD, Ph.D., babban jami'in kula da lafiya a Brii Bio. “Masu ciwon HBV na yau da kullun a halin yanzu suna samun damar yin amfani da jiyya waɗanda ke haifar da ƙimar aikin lambobi guda ɗaya kawai. Muna sa ran yin aiki tare da masu bincikenmu a kasar Sin don tantance aminci da tasirin BRII-179 wajen sake inganta aikin rigakafi na musamman na HBV a cikin wannan yawan majinyata, wanda zai iya fassara zuwa mafi girman adadin magani. "

BRII-179 (VBI-2601) wani labari ne mai sake haɗawa, ɗan takarar HBV na tushen furotin wanda ke bayyana antigens na Pre-S1, Pre-S2, da S HBV, kuma an tsara shi don haifar da ingantaccen rigakafin B-cell da T-cell. . BRII-179 (VBI-2601) yana ginawa akan 3-antigen conformation na VBI Vaccines' prophylactic HBV allurar, wanda aka yarda a Amurka a karkashin sunan PreHevbrio™ [Hepatitis B Vaccine (Recombinant)].

Wannan gwaji na 2 na BRII-179 shine makafi biyu, bazuwar, mai sarrafa wuribo, nazarin rukuni-rukuni don kimanta tasirin asibiti na ƙara BRII-179 (VBI-2601) zuwa PEG-IFN-α da nucleos (t) ide Reverse transcriptase inhibitor (NrtI) daidaitaccen tsarin kulawa a cikin marasa lafiya na HBV marasa cirrhotic. Marasa lafiya da ke shiga cikin binciken sun sadu da ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ra'ayi don amsawar juzu'i ga ci gaba da PEG-IFN-a da NrtI jiyya. Hukumar Kula da Bayanai da Tsaro mai zaman kanta za ta sa ido kan amincin majiyyaci da ingancin jiyya don wannan binciken.

Mataki na 2 a:

• Mataki na 2a na binciken zai ƙayyade inganci da aminci na BRII-179 (VBI-2601) a cikin kusan marasa lafiya na 120 a hade tare da PEG-IFN-α + Nrtl far.

• Mahimmin mahimmanci na Phase 2a shine yawan marasa lafiya da hasara na HBsAg a lokacin kammala jiyya.

Mataki na 2b:

• A cikin Mataki na 2b, binciken zai fadada zuwa marasa lafiya na 480 don kimanta yawan marasa lafiya da ke samun maganin aikin aiki bayan sun karbi maganin BRII-179 (VBI-2601) tare da PEG-IFN-α + NrtI.

• Babban maƙasudin ƙarshe na Mataki na 2b shine yawan adadin marasa lafiya da ke samun ci gaba na HBsAg da asarar DNA na HBV.