お知らせ • Nov 11
Aligos Therapeutics, Inc. Presents Positive Data At the Liver Meeting®? 2025
Aligos Therapeutics, Inc. announced positive data from eight presentations, including one oral presentation, at the American Association for the Study of Liver Disease's (AASLD) The Liver Meeting®? 2025, being held November 7 - 11, 2025 in Washington, D.C. The oral and poster presentations highlighted the best-in-class potential of pevifoscorvir sodium, a potent CAM-E under development for the treatment of chronic hepatitis B virus (HBV) infection. Newly presented data highlight outcomes for treatment-naïve or currently not treated HBeAg+ and HBeAg- subjects who completed 96 weeks of 300 mg pevifoscorvir sodium monotherapy, followed by 8 weeks of nucleos(t)ide analog (NA) monotherapy. Among HBeAg+ subjects, 8 of 10 subjects transitioned to NA monotherapy; of these, 6 (75%) maintained HBV DNA levels below the lower limit of quantification (LLOQ; 10 IU/mL, target detected [TD] or target not detected [TND]) throughout the NA only 8-week follow-up period. In the HBeAg- subjects, 8 of 9 subjects switched to NA monotherapy, and all 8 (100%) subjects maintained HBV DNA < LLOQ (10 IU/mL, TD or TND) throughout the NA only 8-week follow-up period. Reductions in HBV antigen and HBV RNA were also maintained during the NA-only 8-week follow-up period. Notably, these viral biomarkers, such as HBV antigens and HBV RNA, are typically unaffected by NA therapy, suggesting that pevifoscorvir sodium may reduce the cccDNA pool through engagement of its secondary mechanism of action. Additionally, preclinical in vitro data demonstrated that ALG-001075, the active parent moiety of pevifoscorvir sodium, can prevent cccDNA formation and HBV DNA integration. This finding is further supported by cell-based studies presented at the meeting, which showed prevention of cccDNA establishment and HBV DNA integration following treatment with ALG-001075 (Poster #1251). Additionally, the complete 96-week data from the Phase 1 monotherapy (NCT04536337) cohorts were presented showing the continued potential of pevifoscorvir sodium to become first-line therapy for chronic suppression. In all 10 HBeAg+ subjects with very high mean baseline HBV DNA level of 8.0 log10 IU/mL, a rapid, profound, and durable HBV DNA reduction was noted following daily oral dose of 300 mg pevifoscorvir sodium monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, TD or TND). With treatment extension, this rate increased to 10 of 10 subjects (100%) at Week 96. Additionally, HBV DNA level declined below the undetectable level (< LLOQ (TND, =4.29 IU/mL)) in 5 of 10 (50%) subjects at Week 96. In HBeAg- subjects receiving daily dose of 300 mg pevifoscorvir sodium monotherapy, all 11 (100%) had rapid decline in HBV DNA levels < LLOQ (TD or TND) by Week 24 with HBV DNA suppression maintained for up to 96 weeks of treatment; further decline in 8 of 9 (89%) subjects below the undetectable level of HBV DNA to < LLOQ (10 IU/mL, TND) was noted at Week 96. Importantly, no viral breakthrough was observed in any subjects receiving pevifoscorvir sodium monotherapy for up to 96 weeks. Furthermore, concurrent multi-log10 reductions in HBV antigens (HBsAg, HBeAg, and HBcrAg) in HBeAg+ subjects and HBcrAg decline in HBeAg- subjects were observed, suggesting the potential inhibition of cccDNA establishment by CAM-E secondary mechanism of action of pevifoscorvir sodium. A favorable tolerability profile was observed in both HBeAg+ and HBeAg- subjects receiving 300 mg pevifoscorvir sodium for up to 96 weeks.