Aligos, Amoytop Partner for Hepatitis B Trial
Aligos and Amoytop to study ALG-000184 and PEGBING® for chronic hepatitis B in Phase 1b trial.
Breaking News
Jul 23, 2024
Mrudula Kulkarni
Xiamen Amoytop Biotech Co., Ltd. and ligos Therapeutics, a
biopharmaceutical business, have signed a clinical trial partnership agreement.
Under the terms of the agreement, a Phase 1b exploratory clinical trial will be
sponsored and carried out in China to assess the safety and effectiveness of
ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in patients
with chronic hepatitis B (CHB). Following permission by China's National
Medical Products Administration, the clinical investigation is anticipated to
start.
For CHB, a strong oral small molecule capsid assembly
modulator (CAM-E) called ALG-000184 is being developed. It is intended to take
advantage of the dual function of CAMs by decreasing the expression of viral
indicators like DNA, RNA, and pertinent antigens, hence upsetting the levels of
hepatitis B cccDNA and its generated transcripts. In longer-term Phase 1b
studies, ALG-000184 monotherapy has shown best-in-class reductions in HBV DNA,
RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date.
PEGBING®, independently developed by Amoytop, is the world's
first 40kD pegylated interferon α-2b injection; it is primarily used in the
clinical treatment of viral hepatitis and is the first-line medication for the
antiviral treatment of chronic hepatitis B, which is crucial in raising the
clinical cure rate of hepatitis B and lowering the risk of liver cancer. The
Phase 1b study will be a randomised, double-blinded, active-controlled study to
assess the safety, pharmacokinetics