Zhimeng Biopharma, Inc. today announced the initiation of the first-in-human dosing of ZM-H1505R in its Phase I clinical study in the United States.
Shanghai – March 5, 2020. - Zhimeng Biopharma, Inc. today announced the initiation of the first-in-human dosing of ZM-H1505R in its Phase I clinical study in the United States. ZM-H1505R is a novel, investigational HBV capsid formation inhibitor that is being developed by Zhimeng Biopharma for the treatment of chronic HBV infection. Primary results showed that the drug is safe and well tolerated in health volunteers tested.
The current PhaseI clinical trial of ZM-H1505R in the United States 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. Zhimeng anticipates the full results from this study to be released by the third quarter of this year. Immediately following this trial, the clinical study of ZM-H1505R in China with HBV-infected patients will be conducted later this year.
Different from the reported Type I and Type II HBV core protein allosteric modulators (CpAMs), ZM-H1505R is a novel pyrazole molecule that has a new binding site in the HBV core protein. It inhibits HBV replication by hindering the packaging of pre-genomic RNA (pgRNA) into the viral capsid and by blocking the formation of HBV covalently closed circular DNA (cccDNA).
"The first-in-human dosing of ZM-H1505R in the United States is a key step forward in our pursuit of a functional cure for chronic HBV infection. It is also an important milestone for Zhimeng, as it marks our transition to a clinical-stage company,” said Huanming Chen, Ph.D., Chief Executive Officer of Zhimeng Biopharma. “Currently there are about 250 million people worldwide chronically infected by HBV and nearly one million people die from HBV-related liver diseases each year. Current treatments rarely cure the HBV infection and the drugs have to be taken for life. It is clear that there is a significantly unmet need for new drugs for HBV infection. We are excited that the ZM-H1505R-101 clinical trial is underway and hopeful that ZM-H1505R has the potential to become a critical component of a curing regimen for chronic HBV infection”.
For more information about the ZM-H1505R-101 clinical study, please visit clinicaltrials.gov and use the identifier NCT04220801.
About Chronic Hepatitis B Virus (HBV) Infection
According to an estimate by the World Health Organization, HBV is the leading cause of the world’s most common and serious liver infection, with more than 240 million people chronically infected, and approximately 780,000 deaths from HBV-infected diseases. In China alone, roughly 90 million people are chronically infected by HBV, and among those affected, 30 million are in need of chronic treatment.
About Zhimeng Biopharma, Inc.
Founded in 2017, Zhimeng Biopharma’s drug discovery and development falls into two therapeutic areas: chronic hepatitis B virus infection and central nervous disease. The company strives to develop innovative drugs to treat chronic hepatitis B, stroke, epilepsy, and other areas of neurological diseases. Most of Zhimeng’s products will be ready for clinical evaluation in 2021. ZM-H1505R is one of innovative products in Zhimeng’s HBV pipeline. In January 2020, the company announced the approval of its IND from US FDA for starting clinical trial on ZM-H1505R.
This press release contains forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual performance and results to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Except for statements of known facts, information contained herein contains forward-looking statements regarding, among others, (i) the therapeutic and commercial potential of ZM-H1505R and Zhimeng’s other products in pipelines; and (ii) the research and development plans and timelines related to ZM-H1505R and Zhimeng’s other products in pipelines. The readers are advised that the process by which an early stage investigational therapy such as ZM-H1505R could potentially become an approved drug is long and involves significant risks and uncertainties. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities; the unpredictability of the duration and outcomes of regulatory reviews of IND Application and New Drug Application; market acceptance of newly approved products and treatments; and competition. The forward-looking statements contained in this press release reflect Zhimeng's current views with respect to future events. Zhimeng undertakes no obligation to update forward-looking statements if circumstances or company’s estimates or opinions should change except as required by applicable laws. The readers are cautioned not to place undue reliance on forward-looking statements.
Shanghai Zhimeng Biopharma, Inc.
Rong Peng, Ph.D.