Aligos Halting Further Development of Drug Candidate

 Phase 1 data at projected efficacious dose (400 mg) indicate insufficient activity against hepatitis B virus to justify further development

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™ 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.

https://finance.yahoo.com/news/aligos-halting-further-development-stops-130000126.html