The phase 2B trial of vapendavir will use bioMérieux’s Biofire Spotfire panel—a CLIA-waived molecular test that detects rhinovirus—to confirm infections in COPD patients.
Altesa BioSciences has announced a collaboration with bioMérieux to utilize the Biofire Spotfire respiratory solution as the core point-of-care diagnostics platform at US sites for its upcoming Phase 2B clinical trial examining vapendavir, an antiviral treatment for rhinovirus infections in COPD patients.
The randomized, double-blind, placebo-controlled study will recruit 600 participants with GOLD stage II, III, and IV COPD, beginning enrollment in Q1 2026 across US and UK sites. The trial will examine the safety and efficacy of vapendavir in treating rhinovirus infections, which are responsible for approximately half of acute COPD exacerbations.
At US study sites, participants experiencing cold-like symptoms will receive rapid diagnosis using the Biofire Spotfire Respiratory/Sore Throat Panel Mini. The CLIA-waived point-of-care molecular panel can detect coronavirus SARS-CoV-2, human rhinovirus, influenza A and B viruses, and respiratory syncytial virus from a single patient sample within approximately 15 minutes.
“This is the first time the Biofire Spotfire respiratory solution has been used in such a clinical trial, and we appreciate Altesa’s vision in seeking faster evidence to inform clinical decisions,” says John Osiecki, PhD, vice president of medical affairs North America at bioMérieux, in a release.
Enabling Prompt Randomization and Treatment
The rapid diagnostic capability will enable prompt randomization and treatment initiation once rhinovirus infection is confirmed. bioMérieux currently provides the only CLIA-waived point-of-care molecular panel that includes rhinovirus detection, according to a release from the company.
“Altesa and bioMérieux will provide research sites with the Biofire Spotfire System to enable rapid diagnosis of rhinovirus infections. Sites span from large academic sites to community and research sites that may not have this equipment available yet,” says Karen Fusaro, senior vice president of clinical development at Altesa BioSciences, in a release.
The collaboration addresses the clinical need for early intervention in COPD exacerbations. Brett Giroir, CEO of Altesa and former US assistant secretary of health, emphasized the importance of rapid diagnostic capabilities for targeted antiviral treatment. “After creating the test-to-treat paradigm during the COVID-19 pandemic, I want to ensure COPD patients benefit from technologies like Biofire Spotfire that enable the targeted, early use of upstream antiviral medicines like vapendavir,” says Giroir in a release.
Recent data showed that vapendavir improved symptoms and viral load in COPD patients experimentally challenged with rhinovirus infection. If approved, the oral antiviral has the potential to prevent up to 50% of COPD exacerbations, according to Altesa.
The Biofire Spotfire system is FDA-cleared and CLIA-waived for use in low-complexity settings including clinics and physician offices. The platform supports early detection of respiratory pathogens and enables timely treatment decisions that may improve patient outcomes and combat antimicrobial resistance.
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