Aligos Therapeutics Announces Collaboration with Xiamen Amoytop Biotech

Aligos Therapeutics, a clinical-stage biopharmaceutical company specializing in liver and viral diseases, has announced a new collaboration with Xiamen Amoytop Biotech. The agreement will see Amoytop sponsor a Phase 1b clinical study to evaluate the efficacy and safety of Aligos’ drug candidate, ALG-000184, in combination with Amoytop’s PEGBING® (Mipeginterferon alfa-2b), in patients suffering from chronic hepatitis B (CHB) in China. This trial is set to commence once approval is received from China's National Medical Products Administration.

Lawrence Blatt, Chairman, President, and CEO of Aligos Therapeutics, expressed enthusiasm about extending their collaboration with Amoytop, citing the company’s proven value as a partner. The study aims to assess the benefits of combining ALG-000184 with PEGBING®, a drug already approved for CHB treatment in China, potentially offering a new therapeutic approach.

ALG-000184 is an oral small molecule capsid assembly modulator (CAM-E) that targets chronic hepatitis B. Designed to disrupt hepatitis B cccDNA and its transcripts, ALG-000184 reduces the expression of viral markers such as DNA, RNA, and antigens like HBsAg, HBeAg, and HBcrAg. Previous studies, including Phase 1a trials, have indicated that ALG-000184 is well-tolerated with no significant safety concerns and demonstrates strong antiviral activity. Longer-term Phase 1b studies have shown that ALG-000184 can significantly reduce HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg levels without any observed viral breakthrough.

PEGBING®, developed independently by Amoytop, is the world’s first 40kD pegylated interferon α-2b injection. Known for its dual action of inhibiting viral replication and enhancing immune responses, PEGBING® is a first-line treatment for chronic hepatitis B. It plays a crucial role in improving the clinical cure rates for hepatitis B and reducing the risk of liver cancer.

Sun Li, Chairman and CEO of Amoytop, highlighted the significance of this collaboration in liver disease treatment, expressing hope that it will yield new treatment solutions for patients. Amoytop aims to optimize chronic hepatitis B treatment pathways through this partnership, aspiring to develop drugs and drug combinations with enhanced clinical value.

The upcoming Phase 1b study will be a randomized, double-blinded, active-controlled trial. It will evaluate the safety, pharmacokinetics, and antiviral activity of a daily 300 mg dose of ALG-000184 in combination with PEGBING® and entecavir (ETV), compared to other combinations such as ALG-000184 with ETV or PEGBING® with ETV. The trial will involve treatment-naive or currently untreated HBeAg-positive and nucleos(t)ide analog-suppressed HBeAg-negative CHB subjects over a 48-week period.

Aligos Therapeutics, founded in 2018, has a mission to lead in the treatment of liver and viral diseases. The company leverages its extensive expertise and experience in drug development to create potential best-in-class treatments for conditions like metabolic dysfunction-associated steatohepatitis (MASH) and high unmet medical need viruses such as hepatitis B and coronaviruses.

Xiamen Amoytop Biotech, listed on China’s SSE STAR Market, focuses on developing and marketing recombinant protein drugs. Specializing in immune-related cytokine medicines, Amoytop aims to be a leader in addressing systemic immune problems and providing solutions for major diseases like viral hepatitis and malignant tumors. The collaboration with Aligos is expected to further these goals, potentially leading to significant advancements in the treatment of chronic hepatitis B.