Altesa BioSciences and bioMérieux Announce Collaboration for Altesa’s Upcoming Phase 2B COPD Clinical Trial

Original from: bioMérieux

Altesa BioSciences, a clinical stage pharmaceutical company dedicated to preventing and treating rhinovirus infections, one of the leading causes of Chronic Obstructive Pulmonary Disease (COPD) and asthma exacerbations, today announced a partnership with bioMérieux, a world leader in the field of in vitro diagnostics, to utilize the BIOFIRE® SPOTFIRE® respiratory solution as its core point-of-care diagnostics platform at U.S. sites for Altesa’s upcoming Phase 2B clinical trial.  

The trial will be a randomized, double-blind, placebo-controlled study examining the safety and efficacy of vapendavir – a direct acting antiviral medicine – to treat rhinovirus infections in patients with COPD.  Rhinovirus infections are responsible for approximately half of acute exacerbations of COPD, and it is hypothesized that early treatment of rhinovirus infections may prevent respiratory complications and improve recovery time. The study will recruit 600 participants with GOLD stage II, III and IV COPD. 

At U.S. sites, participants begin experiencing cold-like symptoms, they will visit their assigned study site to have the suspected rhinovirus infection diagnosed by the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini. As of now, bioMérieux is the only provider of CLIA-waived POC molecular panel including rhinovirus. 

From a single patient sample, the panel will indicate whether the patient’s signs and symptoms are the result of an infection with Coronavirus SARS-CoV-2 (COVID-19), Human Rhinovirus, Influenza A virus, Influenza B virus, and/or Respiratory Syncytial Virus (RSV) within about 15 minutes so that randomization and treatment can promptly begin.   

“This is the first time the BIOFIRE® SPOTFIRE® respiratory solution has been used in such a clinical trial,” said John Osiecki, Ph.D, Vice President Medical Affairs North America, bioMérieux, “and we appreciate Altesa’s vision in seeking faster evidence to inform clinical decisions.     

“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, SVP, Clinical Development with Altesa BioSciences.    

“People with COPD live in fear that respiratory viruses like rhinovirus can put them in the hospital - or worse.  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,” said Brett Giroir, CEO of Altesa and former US Assistant Secretary of Health and COVID-19 testing czar.”

Source: Altesa BioSciences and bioMérieux Announce Collaboration for Altesa’s Upcoming Phase 2B COPD Clinical Trial