Brii Biosciences Limited, perusahaan multi-nasional ngembangake terapi inovatif kanggo penyakit kanthi kabutuhan medis sing ora terpenuhi lan beban kesehatan umum sing gedhe, wis menehi dosis pasien pertama ing uji klinis Fase 2a / 2b kanggo BRII-179 (VBI-2601) ing pasien karo virus hepatitis B kronis (HBV). Kira-kira 290 yuta wong ing saindenging jagad nandhang infeksi HBV kronis, lan meh 800,000 wong mati saben taun amarga komplikasi kayata sirosis, gagal ati, lan kanker sing ana gandhengane karo HBV.
"BRII-179 duweni potensi kanggo ngilangi toleransi kekebalan lan mulihake utawa nambah respon sel T adaptif lan antibodi marang antigen permukaan HBV. Iki bakal nggawe respon kekebalan tahan kanggo HBV lan nggawe kemungkinan kanggo entuk obat fungsional kanggo infeksi HBV kronis, "ujare Li Yan, MD, Ph.D., kepala petugas medis ing Brii Bio. "Pasien HBV kronis saiki mung duwe akses menyang perawatan sing nyebabake tingkat penyembuhan fungsional siji digit. Kita ngarep-arep bisa kerja bareng karo penyidik ing China kanggo nemtokake safety lan pengaruh BRII-179 ing reinvigorating fungsi imun adaptif khusus HBV ing populasi pasien iki, sing duweni potensi nerjemahake menyang tingkat penyembuhan fungsional sing luwih dhuwur.
BRII-179 (VBI-2601) minangka kandidat imunoterapi HBV basis protein rekombinan anyar sing mratelakake antigen permukaan Pre-S1, Pre-S2, lan S HBV, lan dirancang kanggo ningkatake kekebalan sel B lan sel T. . BRII-179 (VBI-2601) dibangun adhedhasar konformasi 3-antigen vaksin HBV profilaksis VBI Vaksin, sing disetujoni ing AS kanthi jeneng PreHevbrio™ [Vaksin Hepatitis B (Rekombinan)].
Uji coba Fase 2 BRII-179 iki minangka studi klompok paralel kanthi acak, dikontrol plasebo, kanggo ngevaluasi efek klinis saka nambah BRII-179 (VBI-2601) menyang PEG-IFN-α lan nukleo (t) sing ana. )ide reverse transcriptase inhibitor (NrtI) terapi standar-of-care ing pasien HBV kronis non-sirosis. Pasien sing melu sinau wis ketemu kritéria sing wis ditemtokake kanggo respon parsial kanggo perawatan PEG-IFN-α lan NrtI sing terus-terusan. Papan Pemantau Data lan Kaslametan independen bakal ngawasi data keamanan pasien lan khasiat perawatan kanggo panliten iki.
Fase 2a:
• Bagian Phase 2a saka panaliten bakal nemtokake khasiat lan safety terapi BRII-179 (VBI-2601) ing kira-kira 120 pasien kanthi kombinasi terapi PEG-IFN-α + Nrtl.
• Titik pungkasan utama Fase 2a yaiku persentase pasien kanthi mundhut HBsAg nalika rampung perawatan.
Fase 2b:
• Ing Fase 2b, panliten bakal nggedhekake pasien 480 kanggo ngevaluasi proporsi pasien sing entuk penyembuhan fungsional sawise nampa terapi BRII-179 (VBI-2601) kanthi kombinasi PEG-IFN-α + NrtI.
• Titik pungkasan utama Fase 2b yaiku persentase pasien sing ngalami mundhut HBsAg lan HBV DNA sing tetep.
APA sing kudu dijupuk saka ARTIKEL INI:
- This Phase 2 trial of BRII-179 is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding BRII-179 (VBI-2601) to existing PEG-IFN-α and nucleos(t)ide reverse transcriptase inhibitor (NrtI) standard-of-care therapy in non-cirrhotic chronic HBV patients.
- Brii Biosciences Limited, a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, has dosed the first patient in a Phase 2a/2b clinical trial for BRII-179 (VBI-2601) in patients with chronic hepatitis B virus (HBV).
- We look forward to working with our investigators in China to determine the safety and impact of BRII-179 in reinvigorating HBV-specific adaptive immune function in this patient population, which could potentially translate into a significantly higher functional cure rate.
