Ground glass hepatocytes as seen in a chronic hepatitis B liver biopsy. Credit: Nephron.

Clinical-stage biopharmaceutical company Antios Therapeutics has initiated its first-in-human Phase I clinical trial for ATI-2173.

The ATI-2173 is a liver-targeted, orally-administered, small molecule that works against hepatitis B (HBV).

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Antios noted that the study is a randomised, double-blind, placebo-controlled single-ascending dose (SAD) study that will be conducted in healthy participants to evaluate the safety, tolerability, efficiency and pharmacokinetic profile of the compound.

HBV infects the liver and causes infectious hepatitis. It spreads from person to person through the sharing of needles or syringes, sexual intercourse, and from mother to baby during birth.

Chronic liver infection is associated with symptoms such as loss of appetite, nausea, vomiting, fatigue, severe abdominal pain, jaundice, dark-coloured urine, and joint pain.

Antios CEO Abel De La Rosa 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.”

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According to the company, this SAD study will be conducted in up to 35 healthy volunteers randomised into five cohorts of seven subjects each.

The company said that a Phase Ib multiple-ascending dose (MAD) trial in HBV-infected participants is intended to start following the SAD and MAD cohorts completion for the Phase Ia trial.

Antios CMO Douglas Mayers said: “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.”

Based in the US, Antios is engaged in the development of innovative therapies to treat viral diseases.