Antios Therapeutics, Inc. and Assembly Biosciences, Inc. announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios’ investigational proprietary active site polymerase inhibitor nucleotide (ASPIN), vebicorvir (VBR), Assembly Bio’s investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor.
The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics, and antiviral activity of this all-oral triple combination. This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naïve or off-treatment HBeAg negative or positive patients in a 12-week treatment study.
“Antios is focused on developing a functional cure for people living with chronic HBV. ATI-2173 has, to date, demonstrated a generally well-tolerated safety profile, leveraging a unique ASPIN mechanism in clinical development to empower combination therapy. Ultimately, ATI-2173 has the potential to become a cornerstone of a once-daily curative regimen in combination with other agents, like vebicorvir, for the treatment of chronic HBV,” said Gregory Mayes, Chief Executive Officer of Antios.
“Our collaboration with Antios emphasizes our commitment to evaluating the backbone of our core inhibitors plus a nucleos(t)ide analogue in combination with other mechanisms to treat HBV, a cause of chronic infection that can lead to a higher risk of death from cirrhosis and liver cancer,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. “The commitment that we and Antios share to pursue finite and curative therapies for HBV unites us in these research efforts and offers hope for patients.”
About Vebicorvir, Assembly Bio’s Lead HBV Core Inhibitor
Assembly Bio’s HBV portfolio includes three investigational small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.
Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that affects approximately 270 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.
The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.
About Antios Therapeutics, Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development – has the potential, if approved, to become the cornerstone of a curative therapeutic regimen for chronic HBV, a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined.
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets.