Virax Biolabs Completes UK Clinical Recruitment and Reports Constructive FDA Feedback for ViraxImmune™ Study Evaluating T Cell Dysfunction in Post-Acute Infection Syndromes
LONDON, Nov. 3, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ:VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases, today announced that it has successfully completed patient recruitment for its United Kingdom-based, multi-centre clinical study evaluating the performance of the ViraxImmune™ assay in detecting T cell dysfunction in Post-Acute Infection Syndromes ("PAIS"), including Long COVID, post-treatment Lyme disease ("PTLD"), and Myalgic Encephalomyelitis / Chronic Fatigue Syndrome ("ME/CFS").
The study, conducted in collaboration with the UK's National Health Service ("NHS"), has achieved full enrolment ahead of schedule, reaching its target of 160 participants. It was randomised in a 3:1 ratio between symptomatic and non-symptomatic participants, with 40 patients recruited for each of the three symptomatic cohorts representing Long COVID, PTLD, and ME/CFS. The trial is designed to evaluate T cell dysfunction and immune dysregulation underlying the major symptoms observed in PAIS.
The collected clinical samples will now undergo immunological analysis to evaluate the performance of the ViraxImmune™ assay in detecting T cell dysfunction as an aid in diagnosing PAIS in patients experiencing persistent and debilitating fatigue. The results from this analysis are intended to support regulatory submissions in the United Kingdom, including filings with the Medicines and Healthcare products Regulatory Agency ("MHRA"), and may also inform subsequent U.S. submissions.
"It was hugely encouraging to see so many patients from across the country keen to contribute to this important research," said Dr James Shepherd, Consultant in Microbiology and Infectious Diseases at NHS Greater Glasgow and Clyde and Honorary Clinical Senior Lecturer at the MRC-University of Glasgow Centre for Virus Research, who serves as the study's Principal Investigator. "There is enormous demand for improved understanding and diagnostic tools for post-acute infection syndromes. The ViraxImmune™ platform represents an exciting step forward in the scientific and clinical approach to these complex immune conditions."
In parallel, Virax announced that it received final minutes from its productive pre-submission meeting with the U.S. Food and Drug Administration ("FDA") on September 10, 2025, to discuss the proposed regulatory pathway for its ViraxImmune™ T cell assay. The meeting provided constructive feedback on the Company's continued development of the assay for use in patients with post-acute COVID-19 infection. Virax is incorporating the Agency's recommendations into its ongoing clinical and analytical development programs to support progress toward a future submission in the United States. The Company anticipates commencing its U.S.-based clinical study in 2026 in partnership with Emory University.
James Foster, Chief Executive Officer of Virax Biolabs, added:
"Completing full UK clinical recruitment ahead of schedule, alongside receiving constructive FDA feedback, represents an important dual milestone for ViraxImmune™. Together, these achievements strengthen our global regulatory position and advance our goal of enabling T cell-based immune profiling to improve diagnosis and management of post-acute infection syndromes."
Initial read-outs from this longitudinal study are expected in Q2 2026.
About Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is developing T cell-based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of post-acute infection syndromes such as Long COVID and other chronic conditions linked to immune dysregulation.
For more information, please visit www.viraxbiolabs.com.
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