PHILADELPHIA, PA — Virion Therapeutics, LLC said it presented data at the 33rd Conference on Retroviruses and Opportunistic Infections in Denver showing that a single intramuscular dose of its investigational therapy VRON-0200 reactivated hepatitis B virus-specific immune responses in a majority of chronically infected patients, with declines in hepatitis B surface antigen sustained through Day 360.
The late-breaker presentation, delivered by Sue Currie, Ph.D., included results from an ongoing Phase 1b trial evaluating VRON-0200 in patients with chronic hepatitis B infection. The company said the therapy maintained a favorable safety and tolerability profile and showed enhanced activity when combined with antigen-lowering antiviral agents.
Chronic hepatitis B affects an estimated 254 million people worldwide and is associated with approximately 1.1 million deaths annually from liver-related complications. Current standard treatment typically requires lifelong antiviral therapy, and viral rebound often occurs when treatment is discontinued.
Currie said existing and investigational therapies have been limited by their inability to restore patients’ immune responses against the virus. “VRON-0200 is the first new HBV immune modulator since pegylated interferon to show durable clinical activity with sustained and/or improving anti-HBV responses up to one year (360 days) following a single dose,” she said.
The company is developing a Phase 2b trial, known as SPARK-B, to evaluate VRON-0200 in combination with investigational antivirals using what it describes as a “Spark and Fan” approach. The strategy is designed to prime immune responses with VRON-0200 and then boost them with antiviral agents that reduce viral antigens.
Andrew Luber, Pharm.D., chief executive officer of Virion, said VRON-0200 is the company’s first immunotherapy incorporating locally acting checkpoint modifiers, which are intended to enhance immune responses while limiting systemic adverse effects. He said the company plans to share additional data from the Phase 1b trial at future scientific meetings.
Details of the study are available at ClinicalTrials.gov under identifier NCT06070051, and the presentation materials are posted at www.VirionTx.com.
Virion Therapeutics is a clinical-stage biotechnology company developing T cell-based immunotherapies for chronic infectious diseases and cancer.
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