hVIVO has announced the publication of a peer-reviewed paper in Nature Communications detailing key biomarker insights from its COVID-19 human challenge study. The study, the world's first COVID-19 characterization trial, identified blood-based biomarkers capable of distinguishing between early and late phases of SARS-CoV-2 infection and other respiratory viruses.
Biomarker Discovery
The paper, titled "SARS-CoV-2 human challenge reveals single-gene blood transcriptional biomarkers that discriminate early and late phases of acute respiratory viral infections," highlights the identification of biomarkers observable even before PCR testing confirms the presence of the virus. This suggests potential clinical utility in early infection detection and patient stratification for antiviral therapy.
Clinical Significance
These biomarkers could significantly advance the diagnosis and management of both early and late-stage infections. According to Dr. Andrew Catchpole, CSO of hVIVO, human challenge trials allow detailed observation of infection progression, particularly in the early stages, which is not feasible with traditional field studies.
Impact on Drug Development
hVIVO's characterization studies offer biopharma clients precise and actionable insights into specific pathogens, supporting and refining vaccine or antiviral development. These trials provide early human efficacy data, informing later-stage trial design and accelerating the path to market for new drugs.
Addressing Current Challenges
With ongoing development of effective treatments for Omicron and related variants, and new developments in mucosal and multivalent vaccines, hVIVO's work is significant in advancing the next generation of treatments. The company recently secured a £2.5m contract for a COVID-19 Omicron challenge study, with expectations for more extensive trials in 2025 and 2026.
Financial Outlook
hVIVO maintains a strong orderbook and reaffirmed its full-year revenue guidance of £62m, with management projecting full-year EBITDA margins to be at the upper end of market expectations. The company aims for £100m of revenues by FY28, supported by strong sales momentum and a US$37m cash position.
