US biopharma company Antios Therapeutics has initiated its first-in-human phase 1 clinical trial for ATI-2173, a liver-targeted, orally-administered, small molecule against hepatitis B.
The phase 1a study is a randomized, double-blind, placebo-controlled single-ascending dose (SAD) study that will feature healthy volunteers to assess the safety, tolerability and pharmacokinetic profile of the compound.
The SAD trial will be held in up to 35 healthy subjects who will be grouped ramdomly into five cohorts of seven subjects each.
A phase 1b multiple-ascending dose (MAD) clinical study in HBV-infected subjects is expected to begin after the completion of the SAD and MAD cohorts for the phase 1a trial.
Douglas Mayers – CMO of Antios Therapeutics said: “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.
“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.”
According to Antios Therapeutics, ATI-2173 is designed to deliver the 5′-monophosphate of clevudine. The L-nucleoside’s active 5′-triphosphate is believed to have unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor.
Through selective delivery of the 5′-monophosphate to the liver and by retaining the unique anti-HBV activity of the active 5′- triphosphate, the molecule could become an integral part of a curative combination regimen for the treatment of chronic hepatitis B, said the clinical-stage biopharma company.