Dec. 16th, 2021. Shanghai, China. The US Food and Drug Administration (FDA) has approved Shanghai Zhimeng Biopharma, Inc's Investigational New Drug (IND)application for its TLR8 agonist （CB06-036） to start clinical trials for the treatment of chronic hepatitis B virus infection. The planned phase 1 study will start in January 2022 in the US to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of CB06-036 in healthy subjects.
Dr. Chen Huanming, Chief Executive Officer (CEO) of Zhimeng Pharmaceutical, commented that “Our team has been working very bravely and efficiently to explore and find effective medicines to help achieve functional cure of HBV infection. Today we are very pleased to achieve this regulatory milestone on our TLR8 agonist and are excited to bring it to clinical study early next year.”
About 250 million people worldwide are infected with chronic hepatitis B virus (HBV), and about 650,000 people die each year from liver failure, cirrhosis and hepatocellular carcinoma caused by chronic hepatitis B. In China, there are about 90 million people with chronic HBV infection, of which about 30 million have developed chronic hepatitis B who need treatment. The pathogenic mechanism of HBV is complex, and current therapeutic drugs (including nucleoside/nucleotide analogues and immunomodulators) have obvious limitations and are clearly inadequate to address the clinical need for HBV therapeutics. Toll-like receptor 8 (TLR8) recognizes pathogen-derived single-stranded RNA fragments to trigger innate and adaptive immune responses. Chronic hepatitis B (CHB) is associated with a dysfunctional immune response, and therefore a selective TLR8 agonist may be an effective treatment option.
CB06-036 is an orally active, potent and selective toll-like receptor 8 (TLR8) agonist developed at Zhimeng Biopharma for the treatment of hepatitis B virus (HBV). CB06-036 can induces cytokines in human peripheral blood mononuclear cells that are able to activate antiviral effector function by multiple immune mediators.. Preclinical studies show that CB06-036 also has a good liver targeting characteristics.