Shanghai, China. March 31, 2022. Shanghai Zhimeng Biopharma, Inc. (“Zhimeng”), an innovation-driven biopharmaceutical company focused on the development of innovative drugs for the treatment of chronic hepatitis B and central nervous system diseases, announced dosing of the first participant in the US Phase I study of its novel TLR8 agonist (CB06), which is being developed for the treatment of chronic hepatitis B virus infection.
The Phase I clinical trial, a randomized, double-blind and placebo-controlled study, is to evaluate the safety, pharmacokinetics and pharmacodynamics of single escalating doses of CB06 in healthy adult subjects.
“We are pleased to have received FDA approval for the clinical trial and are now moving forward with the first human dosing of CB06, which is a testament to our capabilities in global clinical development.” Said Dr. Huanming Chen, President and Chief Executive Officer of Zhimeng, “Zhimeng plans to submit a clinical trial application to the National Medical Products Administration (NMPA) following the U.S. Phase I clinical trial to fast-track the clinical study of CB06 in chronic hepatitis B patients in China, fulfilling the urgent clinical need to achieve a cure for chronic hepatitis B.”
CB06 is a small molecule, oral TLR8 agonist independently developed by Zhimeng, and it is the second candidate with exclusive intellectual property that successfully enters the clinical development stage, within Zhimeng’s innovative pipelines.
Activating Toll-like receptor 8 (TLR8) triggers innate and adaptive immune responses via recognizing pathogen-derived single-stranded RNA fragments. Since chronic hepatitis B is associated with a dysfunctional immune response, a selective TLR8 agonist may be an effective treatment option.
Preclinical studies have shown that CB06 can induce cytokines in human peripheral blood mononuclear cells, which will activate antiviral effector functions by multiple immune mediators. Preclinical studies also show that CB06 has a good liver targeting activity.
About Chronic Hepatitis B
About 250 million people worldwide are infected with chronic hepatitis B virus (HBV), and about 650,000 people die each year from HBV-related liver failure, cirrhosis, and hepatocellular carcinoma. In China, about 90 million people are infected with chronic HBV, among them about 30 million have developed chronic hepatitis B and need treatment. The underlying pathogenic mechanism of HBV is complex, and current therapeutic drugs (including nucleoside/nucleotide analogs and immunomodulators) have apparent limitations and are inadequate to address the clinical needs for HBV therapeutics.
About Zhimeng Biopharma
Zhimeng Biopharma is a clinical-stage biopharmaceutical company committed to developing innovative drugs to treat chronic hepatitis B virus infection and neurological diseases. Zhimeng has recently announced the successful completion of the Phase Ib clinical trial of its novel HBV capsid inhibitor, Canocapavir (ZM-H1505R), with an upcoming Phase II study to begin shortly. In addition, the company has successfully filed IND application in US for its KCNQ2/3 potassium channel opener for the treatment of epilepsy in December 2021, and the clinical phase I study will be launched soon in the US.
This press release contains forward-looking statements. While Zhimeng considers the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.