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Aligos Therapeutics Announces the Completion of Enrollment in the Phase 2 B-SUPREME Study of Pevifoscorvir Sodium Under Development for the Treatment of Chronic HBV Infection

ALGS
  • Aligos Therapeutics completed enrollment in both Part 1a (131 HBeAg+ participants) & Part 2a (114 HBeAg- participants) of its Phase 2 B-SUPREME study for pevifoscorvir sodium.
  • Topline safety & efficacy data from the B-SUPREME study are expected in late Q3 2027.
  • The second interim analysis for sample size re-estimation will not occur due to over-enrollment prior to that planned analysis.
  • The study compares pevifoscorvir sodium monotherapy against tenofovir disoproxil fumarate in approximately 250 untreated adults with chronic HBV infection over 48 weeks.
  • Primary endpoints include HBV DNA <LLOQ (10 IU/mL) with target not detected (TND) for HBeAg- patients & target detected or not detected (TD/TND) for HBeAg+ patients.
  • Pevifoscorvir sodium is a capsid assembly modulator (CAM-E) derived from Emory University research & optimized by Aligos for chronic HBV treatment.
  • Phase 1 data demonstrated the drug was well-tolerated, showed linear pharmacokinetics, & produced sustained reductions in HBV DNA, RNA, & antigens up to 96 weeks.
  • Regulatory pathways for pevifoscorvir sodium have been acknowledged by the FDA, EMA, & NMPA for chronic suppressive studies.
  • Chronic HBV infection affects 240 million people globally & caused approximately 1.1 million deaths in 2024 due to complications like cirrhosis & liver cancer.
  • Aligos Therapeutics (NASDAQ: ALGS) is a clinical-stage company focused on developing therapies for liver & viral diseases including HBV, MASH, obesity, & coronaviruses.