Shanghai Zhimeng Biopharma, Inc. announced that the United States Food and Drug Administration (FDA) approved its investigational new drug (IND) application of HBV capsid inhibitor ZM-H1505R to start the phase 1 clinical trial for the treatment of chronic hepatitis B virus infection.
January 15th, 2020. Shanghai, China. Shanghai Zhimeng Biopharma, Inc. announced that the United States Food and Drug Administration (FDA) approved its investigational new drug (IND) application of HBV capsid inhibitor ZM-H1505R to start the phase 1 clinical trial for the treatment of chronic hepatitis B virus infection.
The upcoming phase 1 clinical trial is a randomized, double-blind, placebo-controlled sequential single and multiple ascending dose (SAD/MAD) study following oral administration in healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of ZM-H1505R.
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.
ZM-H1505R is an investigational HBV capsid formation inhibitor that is being developed by Zhimeng Biopharma for the treatment of HBV infection. Different from the reported Type I and Type II HBV core protein allosteric modulators (CpAMs), ZM-H1505R is a novel pyrazole molecule and has a new mechanism of action. It hinders the packaging of pre-genomic RNA (pgRNA), and effectively blocks the formation of HBV cccDNA.
Preclinical virology data demonstrates that ZM-H1505R effectively inhibits HBV replication in both in vitro and in vivo models. ZM-H1505R is highly active against major HBV genotypes (A, B, C, and D). ZM-H1505R has potential in overcoming resistance to nucleoside/nucleotide analogues or reported type I and type II CpAMs and shows additional therapeutic effect when combined with existing SOCs. Preclinical data also shows that ZM-H1505R has an excellent safety profile and ideal bioavailability and metabolic stability, with clear metabolic pathways and metabolites.
Besides ZM-H1505R, Zhimeng’s HBV pipeline also includes RNA destabilizers that inhibit the expression of hepatitis B virus surface antigens and other viral proteins and immune modulators. Zhimeng’s strategy is to inhibit viral replication and viral protein expression in multiple ways, while simultaneously induce an effective antiviral immune response to suppress the virus and ultimately achieve a functional cure for chronic hepatitis B.
Dr. Huanming Chen, founder and CEO of Zhimeng Biopharma, said: “Since the establishment of the company in November 2017, it took only two years for us to complete the IND research, application and get approval of ZM-H1505R by the US FDA for phase 1 clinical trial. It’s an important milestone for Zhimeng Biopharma, and is a true reflection of our employees’ hard work, as well as the great supports of our collaborators.
Zhimeng Biopharma focuses on the discovery and development of innovative therapies for treating chronic HBV infection and neurological diseases. In addition to ZM-H1505R, the company plans to bring its innovative drug products for treatment of epilepsy and other products in pipelines to clinical research in the next 1-2 years. Zhimeng Biopharma strives for excellence, integrity and compassion, and is committed to provide more effective, safe and affordable drugs to patients around the world."