HH-003 — the world’s first HBV neutralizing antibody targeting the pre-S1 domain of the HBV large envelope protein, developed by Huahui Health, unveiled its clinical data for the first time
HH-003 demonstrated favorable safety, tolerability, pharmacokinetics and antiviral activity in treatment-naïve, HBeAg-positive chronic HBV infection participants in a randomized, multi-center, double-blind, placebo-controlled, multiple ascending dose Phase Ib study
【Beijing, China – November 8, 2022】– Huahui Health, a Beijing-based, clinical stage biotechnology company focused on discovering and developing virology, hepatology and oncology therapies, announced the results from the Phase Ib first-in-patient study of HH-003, the world’s first anti-PreS1 hepatitis B virus (HBV) neutralizing antibody, in treatment-naïve, HBeAg-positive chronic HBV infected patients at the 2022 American Association for The Study of Liver Diseases (AASLD) annual conference.
Prof. Jidong Jia M.D., from Beijing Friendship Hospital, Capital Medical University, China, presented the safety, tolerability, pharmacokinetics, and preliminary efficacy data from the HH-003 Phase Ib study at the AASLD 2022. “The discovery of NTCP (sodium taurocholate co-transporting polypeptide) receptor by Prof. Wenhui Li, scientific founder of Huahui Health, generated optimism in the field that a functional cure for hepatitis B may be possible. HH-003 is designed to inhibit the PreS1 domain on HBV particle to block the virus from engaging with NTCP receptor on hepatocytes.” said Prof. Jidong Jia M.D, “HH-003 demonstrated favorable safety profile and antiviral activity in the study. In the immune-active cohort after 3 doses twice a week treatment, we observed significant decrease of HBsAg. We share the same goal with Huahui Health to cure chronic hepatitis B and look forward to generating more clinical data for HH-003.”
“We are encouraged by the preliminary clinical data demonstrated by HH-003. Patients enrolled in the study are treatment-naïve HBV patients in immune tolerant or clearance, we observed promising antiviral response in those patients in immune clearance period after 3 doses twice a week treatment and in follow-up visits.” said Prof. Niu Junqi M.D., from the First Hospital of Jilin University, Changchun, China, a primary investigator of the study.
“HH-003 is a ‘first-in-class’ anti-HBV antibody with dual mechanism of action. It can block the viral entry to hepatocytes to break the circle of de novo infection and re-infection in liver. Meanwhile, it can potentially clear the free virions and infected hepatocyte through Fc-dependent immunological effector functions. As of now, HH-003 has 3 Phase II clinical trials in progress to further evaluate its safety and efficacy in hepatitis B & hepatitis D. We’re striving to bring a new therapeutic option for patients in China and across the globe hopefully sooner than expected.” commented Bin Chen, Ph.D., CEO of Huahui Health.
Chronic hepatitis B remains a significant major health problem in many countries and regions. According to the WHO statistics, there are approximately 296 million people infected by HBV worldwide who are at high risk of developing liver cirrhosis and hepatocellular carcinoma (HCC). As of today, there’s no therapeutic options that could achieve a functional cure of chronic hepatitis B.
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