Oral TRL8 agonist completed the first human administration in phase 1 clinical practice

2022-04-13

(WuXi AppTec) On April 2, 2022, focused on the liver and central nervous system diseases in the field of biological innovation, ZM BIOPHARMA announced that its independent research and development of small molecules, used in the treatment of chronic hepatitis b oral TLR8 agonist CB06 healthy subjects for the first time to complete a phase 1 clinical trials in the United States drug use. CB06 is a small molecule oral TLR8 agonist independently developed by ZM BIOPHARMA, and is the second independent innovation candidate in the company's r&d pipeline to enter clinical trials.

Chronic hepatitis B is one of the major public health problems. Public data show that more than 200 million people worldwide are chronically infected with the hepatitis B virus (HBV). Hepatitis B virus infection is the main cause of liver disease, and about hundreds of thousands of people die each year from chronic hepatitis B-induced liver failure, cirrhosis and hepatocellular carcinoma. The pathogenesis of hepatitis B virus is complex, and the existing therapeutic drugs are far from meeting the clinical needs.

TLR8, full name toll-like receptor 8, recognizes pathogen-derived single-stranded RNA fragments to trigger innate and adaptive immune responses. Studies have found that chronic hepatitis B is associated with a dysfunctional immune response, so selective TLR8 agonists are considered to be a potentially effective treatment option.

CB06 has shown good selectivity, activity and safety in preclinical studies, and can induce cytokines in human peripheral blood monocytes, which can activate antiviral function through a variety of immune mediators, according to a press release from ZM BIOPHARMA. At the same time, CB06 has good liver targeting characteristics.

The phase 1 trial of CB06 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of a single incremental dose of CB06 in healthy adult subjects.

"We are pleased with the progress and completion of the first human administration of CB06 following the FDA clinical trial approval, which is a testament to Our global clinical research and independent r&d capabilities." "Based on the completion of the phase 1 clinical trial of CB06, We plan to rapidly advance the clinical trial of CB06 in China to meet the urgent clinical needs of chronic hepatitis B," said Dr. Chen, CHIEF Executive Officer (CEO) .

Public information shows that ZM BIOPHARMA is a clinical research and development stage of medical science and technology, focusing on liver diseases and central nervous system diseases of the original drug research and development. The company's core program, a novel nucleocapsid inhibitor against hepatitis B virus (ZM-H1505R), has completed clinical Ib studies and will soon start a phase 2 clinical study. TLR8 agonist CB06 is the second drug candidate in the company's pipeline to enter clinical trials.

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Oral TRL8 agonist completed the first human administration in phase 1 clinical practice