HBV-TAG: Presentation of in vitro antiviral activity and Phase 1a healthy volunteer data demonstrating the safety, tolerability, and favorable pharmacokinetics of multiple ascending doses of ATI-2173
Pharmacokinetics, antiviral efficacy, and safety of ATI-2173 from a Phase 1b trial in chronic HBV-infected subjects will be presented for the first time at the European Society of Liver Diseases (EASL) International Liver Congress™ 2021 on June 23
MENDHAM, NJ, June 11, 2021 (GLOBE NEWSWIRE) – Antios Therapeutics, Inc. (“Antios”) today announced that the Company is presenting in vitro and Phase 1a data on ATI-2173, a liver targeting Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development as a component of a potentially curative regimen for chronic hepatitis B (HBV) infection, at the 2021 HBV-TAG (Hepatitis B -Therapeutic Agents) Conference, being held virtually on June 11 to 12.
Details of the poster presentation at HBV-TAG are as follows:
Title: ATI-2173, a novel active site polymerase inhibitor nucleotide (ASPIN) for HBV cure regimens, is well tolerated and has favorable pharmacokinetics in healthy volunteers
Authors: Mayers, D., et al.
The poster and accompanying slide presentation can be found on the Antios website at antiostherapeutics.com/publications.
In the study, the antiviral activity and resistance of ATI-2173 alone and in combination with nucleos(t)ide analogues, interferon, and a capsid inhibitor were evaluated, in vitro, in liver cell lines and primary human hepatocytes. Systemic and hepatic concentrations of both clevudine and its phosphoramidate prodrug, ATI-2173, were evaluated in two animal models. ATI-2173 demonstrated potent antiviral activity in vitro as a monotherapy, and additive or synergistic activity with traditional nucleos(t)ides and other direct-acting antivirals. ATI-2173’s ability to selectively target the liver while minimizing systemic exposure was demonstrated in both animal models when compared to the high systemic exposure of clevudine. Safety, tolerability and pharmacokinetics (PK) were evaluated in a Phase 1 clinical trial in healthy volunteers. In healthy human subjects, ATI-2173 was well tolerated with headache being the most common adverse event. The PK profile was dose-proportional with Cmax well-below the Cmin reported with clevudine administration at the marketed 30 mg dose.
Pharmacokinetics, antiviral efficacy, and safety of ATI-2173 from a Phase 1b trial in chronic HBV-infected subjects will be presented for the first time at the upcoming European Society of Liver Diseases (EASL) International Liver Congress™ 2021 to be held virtually on June 23.
ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.
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. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B-infected patients with a curative combination regimen.
+1 (212) 300-8331