Antios Therapeutics has initiated its first-in-human Phase I clinical trial for ATI-2173, a novel liver-targeted, orally-administered, small molecule against hepatitis B. The Phase Ia study is a randomized, double-blind, placebo-controlled single-ascending dose (SAD) study in healthy volunteers to evaluate the compound's safety, tolerability and pharmacokinetic profile.
This SAD study will be conducted in up to 35 healthy subjects randomized into 5 cohorts of 7 subjects each. A Phase Ib multiple-ascending dose (MAD) clinical study in HBV-infected subjects is planned to commence following the completion of the SAD and MAD cohorts for the Phase Ia study.
"Dosing the first patients with ATI-2173 is a significant milestone for our company and we are very excited to initiate the first-in-human study of our liver-targeted, non-chain terminating, HBV polymerase inhibitor," said Abel De La Rosa, Ph.D., CEO of Antios.
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"We are looking forward to learning more about ATI-2173 in the clinic after obtaining very encouraging preclinical antiviral activity and preclinical safety data for our lead molecule," said Douglas Mayers M.D., CMO of Antios.
ATI-2173 is a novel liver-targeted molecule designed to deliver the 5'-monophosphate of clevudine. This L-nucleoside's active 5'-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor. By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the active 5'- triphosphate, ATI-2173 could become an integral part of a curative combination regimen for chronic hepatitis B.