Phase 2b clinical trialPhase 2b clinical trial1

Evaluating the safety and efficacy of ATI-2173 in combination therapy

ANTT203, a phase 2b, multicenter, randomized, double-blind, placebo-controlled trial, is currently being planned. This study will evaluate the safety and efficacy of ATI-2173 combined with nucleoside analogues (NAs) compared to NAs alone for the treatment of chronic hepatitis B virus (HBV) infection.

Study design

Primary endpoint:
HBV DNA below the limit of quantification (BLQ) 24 weeks post treatment

Secondary endpoint:
HBsAg and safety

N=150 Randomized 1:1:1

  • ATI-2173 25 mg + NA (n=50)
  • ATI-2173 50 mg + NA (n=50)
  • TDF alone (n=50)
  • Cohort 1: 40 on 25 mg: 40 on 50 mg: 40 on TDF alone: stratified by HBV DNA (> or < 106 IU/mL); primary endpoint HBV DNA BLQ at FU 24 weeks
  • Cohort 2: 10 on 25 mg: 10 on 50 mg: 10 on TDF alone: not stratified; primary endpoint antiviral response at end of treatment
  • Cohort 1: 40 on 25 mg: 40 on 50 mg: 40 on TDF alone: stratified by HBV DNA (> or < 106 IU/mL); primary endpoint HBV DNA BLQ at FU 24 weeks
  • Cohort 2: 10 on 25 mg: 10 on 50 mg: 10 on TDF alone: not stratified; primary endpoint antiviral response at end of treatment

We will continue to update our site with new findings as ANTT203 proceeds.

Reference: 1. Data on file. Antios Therapeutics, Doylestown, PA.

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