Core Insights - Aligos Therapeutics has entered into a clinical trial collaboration with Xiamen Amoytop Biotech to sponsor a Phase 1b study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® for chronic hepatitis B patients in China [1][2] Group 1: Clinical Study Details - The Phase 1b exploratory clinical study will assess the combination of ALG-000184 and PEGBING® in chronic hepatitis B patients, pending approval from the National Medical Products Administration in China [1] - The study will be randomized, double-blinded, and active-controlled, focusing on safety, pharmacokinetics, and antiviral activity over 48 weeks [3] Group 2: Drug Information - ALG-000184 is a first-in-class oral small molecule capsid assembly modulator designed to disrupt hepatitis B cccDNA levels and reduce viral markers [2] - Phase 1a studies have shown ALG-000184 to be well-tolerated with no safety signals and demonstrated linear pharmacokinetics and strong antiviral activity [2] - PEGBING®, developed by Amoytop, is the first pegylated interferon α-2b injection and is a first-line treatment for chronic hepatitis B, enhancing immunity and inhibiting viral replication [3] Group 3: Company Background - Aligos Therapeutics, founded in 2018, aims to be a leader in liver and viral disease treatments, focusing on developing best-in-class therapeutics for unmet medical needs [4] - Xiamen Amoytop Biotech specializes in R&D, manufacturing, and marketing of recombinant protein drugs, particularly in immune-related cytokine medicines [5]
Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.