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Virax Biolabs Makes Significant Progress with ViraxImmune™ Study

Virax Biolabs Group Limited, traded on NASDAQ under the symbol VRAX, recently announced a major milestone in its clinical study for the ViraxImmune™ assay. This innovative biotechnology company, dedicated to the detection and diagnosis of viral-induced immune responses, completed the recruitment phase in the UK significantly ahead of schedule. The multi-centre clinical trial aims to assess T cell dysfunction in patients experiencing Post-Acute Infection Syndromes (PAIS), which includes conditions such as Long COVID, post-treatment Lyme disease (PTLD), and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

The study, executed in collaboration with the UK’s National Health Service (NHS), reached its goal of enrolling 160 participants, including 40 patients from each of the three symptomatic categories. The randomization of participants was conducted with a 3:1 ratio of symptomatic to non-symptomatic individuals. This careful structuring is designed to provide a comprehensive analysis of T cell dysfunction and immune dysregulation that often accompanies PAIS.

Once collected, these clinical samples will undergo rigorous immunological analysis to determine the effectiveness of the ViraxImmune™ assay in detecting T cell dysfunction. The results of this analysis will not only contribute to the understanding of these complex syndromes but also will be pivotal in regulatory submissions in the UK, specifically with the Medicines and Healthcare products Regulatory Agency (MHRA), with potential implications for future submissions in the United States.

Dr. James Shepherd, a principal investigator and a Consultant in Microbiology and Infectious Diseases at NHS Greater Glasgow and Clyde, expressed enthusiasm regarding the wide participation from patients across the UK. He noted, “There is enormous demand for improved understanding and diagnostic tools for post-acute infection syndromes.