Aligos Reports Positive Interim Data, Expands Phase 2 HBV Study As FDA Grants Fast Track Status To Pevifoscorvir

Aligos Therapeutics has reported interim results from its Phase 2 B-SUPREME study evaluating pevifoscorvir sodium in patients with chronic Hepatitis B (HBV). The independent Data Safety Monitoring Board (DSMB) recommended continuing the trial and increasing the sample size in the HBeAg-negative cohort to strengthen statistical power, as the study did not meet futility criteria, indicating continued potential for treatment benefit.

The interim analysis was conducted after approximately 60% of participants in the HBeAg-negative cohort reached at least Week 12. Based on the findings, the sample size for this group will be expanded from 74 to 100 participants. Safety data from all enrolled patients showed that pevifoscorvir sodium was generally well tolerated, with no significant concerns observed in laboratory results, vital signs, or ECG findings, and no evidence of viral breakthrough to date.

“We are encouraged by this recommendation from the DSMB to increase the sample size in order to increase the probability for success of the study’s primary endpoint,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We believe we can enroll the necessary study participants in the coming months, with topline data on track for 2027. Additionally, I am thrilled to share that pevifoscorvir sodium has been granted Fast Track Designation. Aligos’ mission since its founding has been to improve outcomes for patients with unmet needs in liver and viral diseases and being granted Fast Track Designation for pevifoscorvir sodium is the next step in our journey to make this a reality. As we progress the Phase 2 B-SUPREME study, we look forward to working with regulators to determine the appropriate path forward.”

In parallel, the U.S. Food and Drug Administration has granted Fast Track Designation to pevifoscorvir sodium, recognizing its potential as a first- or best-in-class capsid assembly modulator (CAM-E) for chronic HBV treatment. The designation is supported by earlier Phase 1 data demonstrating favorable safety and meaningful reductions in key viral markers, highlighting its promise in addressing an unmet medical need.

Enrollment in the HBeAg-negative cohort is expected to be completed in the second half of 2026, with topline results anticipated in 2027. Fast Track status will enable closer regulatory engagement and may allow for expedited review pathways, reinforcing the therapy’s development momentum.