Aligos craters as it halts development of hepatitis B candidate

US biopharma company Aligos Therapeutics (Nasdaq: ALGS) yesterday revealed that it has halted further development of its STOPS drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB), with the news sending the firm’s shares tumbling 57% to $4.59 on Thursday.

This decision is based on emerging data from the Phase I Study ALG-010133-101 that indicate that at the projected efficacious dose (400mg, 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 600mg) 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.