VNRX-9945 Selected as 3rd Generation Hepatitis B Virus Orally Bioavailable CpAM;
Clinical Trial Application and Phase 1 Planned for Second Quarter 2021
Malvern, PA, March 10, 2021 – Venatorx Pharmaceuticals today announced that it has selected VNRX-9945, a core protein allosteric modulator (CpAM), as a clinical candidate for the treatment of chronic Hepatitis B Virus (HBV) infection. The Company plans to initiate clinical development in the second quarter 2021.
VNRX-9945 is a 3rd generation (highly potent), dual-mechanism viral replication inhibitor with activity against both nucleocapsid assembly and formation of cccDNA. VNRX-9945 demonstrates broad antiviral activity against multiple HBV genotypes in vitro and suppresses HBV DNA to below the lower limit of qualification in a mouse model of HBV infection.
There are over 250 million individuals chronically infected with chronic HBV worldwide who are at risk from complications due to liver disease and liver cancer. Chronic HBV infection is currently managed with nucleos(t)ide reverse transcriptase inhibitors (NrtIs) or pegylated-interferons that suppress HBV DNA replication and normalize alanine aminotransferase (ALT) levels leading to reductions in morbidity and mortality. Unfortunately, however, these agents are not curative and patients generally exhibit poor off-treatment responses that require indefinite therapy.
“Functional cure for chronic HBV infection remains the ultimate goal of HBV therapy,” said Christopher J. Burns, Ph.D., President and CEO of Venatorx. “The discovery and advancement of highly potent CpAMs, including VNRX-9945, represents an exciting opportunity to achieve deeper and more complete levels of antiviral suppression in chronic HBV patients, and has the potential to form the basis for future combination therapies that lead to a functional cure.”
“We have been actively pursuing next-generation CpAMs that could be included in a future combination regimen for the treatment of chronic HBV infection,” said Dr. Glen Coburn, Director of Virology at Venatorx. “Using a structure-assisted drug design approach, we identified VNRX-9945, a compound that exhibits antiviral activity that is amongst the best-in-class and possesses excellent oral bioavailability and safety properties. We look forward to facilitating the inclusion of VNRX-9945 in future combination regimens. Combining direct-acting antivirals with agents that knockdown antigen expression or stimulate immune responses may hold the key to optimizing treatment outcomes in patients with chronic HBV infection.”
Venatorx is pursuing mutually beneficial partnership and/or collaboration opportunities for VNRX-9945.
About Venatorx Pharmaceuticals
Founded in 2010, Venatorx Pharmaceuticals is a private pharmaceutical company focused on improving health outcomes for patients with multi-drug-resistant bacterial infections and hard-to-treat viral infections. Venatorx has built a world-class in-house research and development organization that has filed over 120 patents. Venatorx’s two lead antibacterial clinical-stage programs are intravenous (cefepime-taniborbactam) and oral (ceftibuten/VNRX-7145) broad-spectrum beta-lactam / beta-lactamase inhibitor combinations that are in Phase 3 and Phase 1, respectively. In addition, Venatorx is entering clinical development this year with its first antiviral compound (VNRX-9945), a Hepatitis B virus inhibitor. The Company is also developing a novel class of non-beta-lactam antibiotics called Penicillin Binding Protein (PBP) inhibitors that have the potential to circumvent 70+ years of resistance and usher in a new wave of antibacterial therapeutics. For more information about Venatorx, its partners, investors and pipeline development, please visit www.venatorx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.