Benzinga | Jan 6, 2022 08:14AM EST

Aligos Halting Further Development Of STOPS Drug Candidate, ALG-010133

Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has halted further development of its STOPS(tm) drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB). This decision is based on emerging data from the Phase 1 Study ALG-010133-101 that indicate that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there is no meaningful HBsAg reduction. Furthermore, higher doses levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that Aligos had previously defined as necessary to advance the program. No dose-limiting safety findings have been identified in CHB subjects dosed at any dose level. Based on this information, Aligos management reviewed the data with members of the study's Study Review Committee (SRC) and jointly concluded that these data were not sufficient to support further development of ALG-010133 and that dosing should be discontinued.



"We are disappointed that the antiviral activity data from this study indicate that ALG-010133 cannot meaningfully contribute to achieving functional cures in CHB," said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. "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."