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Item 8.01 Other Events.
On January 6, 2022, Aligos Therapeutics, Inc. (the “Company”) announced that it had halted further development of its STOPSTM 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 the Company 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, Company management reviewed the data with members of the study’s Study Review Committee and jointly concluded that these data were not sufficient to support further development of ALG-010133 and that dosing should be discontinued.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|ALIGOS THERAPEUTICS, INC.|
|Date: January 6, 2022||By:|
|Lesley Ann Calhoun|
|Executive Vice President, Chief Financial Officer|