Our HBV-Cure program aims to develop curative therapies for chronic HBV, a poorly-treated condition that affects hundreds of millions of people around the globe.
Chronic hepatitis B virus (HBV) is a debilitating infectious disease of the liver that afflicts an estimated 240 million people worldwide and is a leading cause of chronic liver disease and liver transplants. It is an underappreciated global epidemic that afflicts twice as many people as hepatitis C virus (HCV) and HIV infection combined, with a higher mortality and morbidity rate. An estimated 500,000 to one million people die every year from HBV-related causes. The Centers for Disease Control (CDC) reports that almost two million people in the US are chronically infected with HBV. There is high unmet need for better therapies for chronic HBV – the current standard of care cannot cure the condition in more than 90% of patients, who are at risk for developing severe, potentially fatal liver diseases.
Assembly's antiviral program aims to achieve a functional cure for chronic hepatitis B virus infection. A focus of this program is HBV core protein, which is associated with functions that are essential for HBV survival and persistence. The HBV core protein is a highly conserved viral protein that has no human homologue and is involved in the entire HBV lifecycle. It also is implicated in regulating the immune response to HBV.
Assembly is developing several novel series of agents that modulate the HBV core protein, a key viral protein involved in multiple critical functions. These are known as core protein allosteric modifiers, or CpAMs. Assembly researchers believe they have the potential to eliminate HBV by modulating core protein at multiple complementary points in the viral lifecycle. Assembly has demonstrated preclinical proof of principle that CpAMs can selectively reduce both the production of key viral antigens and viral load.
Assembly's first generation lead molecule has shown potent activity across multiple viral genotypes and is currently in a Phase 1 trial. More information about this study can be found at www.clinicaltrials.gov. The CpAM platform offers opportunities for a multi-generation pipeline, and Assembly plans to move its second generation CpAMs into development soon after the first generation program advances.
Assembly's scientists are also investigating other HBV targets that may be complementary to core protein. We anticipate that combinations of therapies will likely be most effective in achieving functional HBV cures, and our research program is aimed at identifying and developing curative combinations.