Aligos Therapeutics has stopped further development of ALG-010133, its STOPS drug candidate, in chronic hepatitis B (CHB) owing to futility.

The California-based clinical stage biopharma company said that the decision has been driven by emerging data from the ALG-010133-101 phase 1 clinical trial that suggests there is no meaningful reduction of Hepatitis B surface antigen (HBsAg) at the projected efficacious dose of ALG-010133 400mg.

According to Aligos Therapeutics, higher doses levels with a maximum feasible dose of 600mg, which were intended to be assessed in a subsequent cohort are highly unlikely to achieve the 1 log10 IU/mL HBsAg reduction level that the company had defined previously as necessary to advance the clinical development in chronic hepatitis B.

Aligos Therapeutics said that its management looked into the data of the ALG-010133-101 trial with the study’s study review committee members and jointly ruled that the data were not enough to support further development of the STOPS drug candidate and that dosing should be stopped.

Lawrence M. Blatt — Chairman and CEO of Aligos Therapeutics said: “We are disappointed that the antiviral activity data from this study indicate that ALG-010133 cannot meaningfully contribute to achieving functional cures in CHB.

“Hepatitis B is a very challenging virus that will likely require combination regimens involving distinct mechanisms of action (MOAs) in order to achieve functional cure. Aligos’ pipeline is deep, with multiple additional MOAs – ASO, siRNA, CAM I, CAM-2 and PD-L1 inhibitors – many of which are clinically validated and have potentially best-in-class properties.

“Two drug candidates with these MOAs – ALG-000184 (CAM-2) and ALG-020572 (ASO) – are currently in the clinic and a third (ALG-125755, siRNA) is projected to be in the clinic mid-year 2022. We continue to be confident that Aligos’ pipeline has the potential to enhance functional cure rates in patients with CHB.”

  ALG-010133, Aligos Therapeutics, California, chronic hepatitis B, clinical trial news, Lawrence M. Blatt, liver diseases, Liver Disorders, USA