Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing transformative treatments for hepatitis B virus (HBV), announced new data from the Phase 2a clinical trial of ATI-2173, its lead investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. Antios also announced new data on its 4th generation capsid assembly modulator (CAM) program evaluating ATI-1428 and ATI-1645. In the 90-day Phase 2a trial, adult patients receiving ATI-2173 in combination with tenofovir disoproxil fumarate (TDF) showed slower virologic rebound than patients receiving TDF plus placebo after stopping treatment. Additionally, in a nonclinical study, low oral doses of ATI-1428 and ATI-1645 given once-daily blocked hepatic HBV replication and reduced both serum HBV DNA and RNA to undetectable levels. These data were presented at the European Association for the Study of the Liver’s International Liver Congress 2022 (EASL ILC 2022).
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“The nonclinical data supports our view that clinical development of 4th generation CAM compounds has the potential to provide a safe and effective approach for treating HBV,” said Luca Guidotti, M.D., Ph.D., Deputy Scientific Director of San Raffaele Hospital and Scientific Advisor to Antios. “By preventing the abnormal capsid accumulation that less potent CAMs induce, these ultra-potent CAMs are designed to not sensitize hepatocytes to unnecessary T cell-mediated killing. This may allow the development of safe and effective combinations with therapeutic strategies aimed at immune reactivation.”
ATI-2173, Antios Therapeutics‘ lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to be a bridge to a potential cure for HBV. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure.