Aligos Therapeutics reports Phase 2 interim data for pevifoscorvir sodium in chronic HBV, with DSMB backing trial expansion and FDA Fast Track designation supporting accelerated development.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Aligos Therapeutics reported first interim results from the Phase 2B-SUPREME study evaluating pevifoscorvir sodium in patients with chronic hepatitis B virus (HBV) infection. The independent Data Safety Monitoring Board (DSMB) recommended continuing the study and increasing the sample size in the HBeAg-negative cohort (Part 2a) from 74 to 100 participants to improve statistical power. The predefined futility criteria were not met, supporting ongoing development.
The interim analysis included approximately 60% of HBeAg-negative participants (n=34) who had reached at least Week 12, along with safety data from all enrolled participants (n=174).
Favorable Safety Profile and No Viral Breakthrough Observed
The investigational therapy demonstrated a favorable safety profile, with no clinically significant abnormalities reported in laboratory tests, physical examinations, vital signs, or ECG findings. No viral breakthrough related to the study drug has been observed to date.
Aligos remains blinded to individual patient-level data. Enrollment completion for the HBeAg-negative cohort is expected in the second half of 2026, with topline results anticipated in 2027.
FDA Fast Track Designation Strengthens Development Path
U.S. Food and Drug Administration has granted Fast Track designation to pevifoscorvir sodium, an oral capsid assembly modulator (CAM-E) under investigation for chronic HBV treatment. The designation was supported by Phase 1 data demonstrating tolerability and reductions in key viral markers over 96 weeks of treatment.
Fast Track designation is intended to accelerate development and regulatory review for therapies addressing serious conditions with unmet medical needs. It enables closer interaction with regulators and may allow eligibility for rolling review and priority pathways.
Executive Perspective on Study Progress and Regulatory Milestone
Lawrence Blatt, Chairman, President, and CEO of Aligos, stated that the DSMB’s recommendation to increase sample size strengthens the probability of achieving the study’s primary endpoint. He added that the company expects to complete enrollment in the coming months and remains on track for 2027 topline data. He also highlighted the Fast Track designation as an important step toward advancing treatment options for patients with chronic HBV infection.
Study Design and Clinical Objectives
The Phase 2 B-SUPREME study (NCT06963710) is a randomized, double-blind, active-controlled trial comparing pevifoscorvir sodium with tenofovir disoproxil fumarate in approximately 200 untreated adult patients with chronic HBV infection. The study evaluates viral suppression endpoints, including HBV DNA reduction below quantifiable levels, along with safety, pharmacokinetics, and biomarker outcomes over 48 weeks.
A second interim analysis is expected in the second half of 2026.
Disease Burden and Unmet Need
Chronic HBV infection remains a major global health challenge, affecting approximately 254 million people worldwide. The disease can lead to cirrhosis, liver failure, and hepatocellular carcinoma, contributing to over one million deaths annually. Despite the availability of vaccines, new infections continue to occur, underscoring the need for more effective therapeutic options.
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About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.