Tetra Bio-Pharma Inc. has signed an agreement with Cellvera Global Holdings LLC for the co-development of ARDS-003 as a combination product, with Qifenda 400MG (Favipiravir), a commercial-stage broad-spectrum antiviral drug.   
 
As a monotherapy, compared to placebo, ARDS-003 dose-dependently reduced signs of morbidity and mortality, including respiratory distress following SARS-CoV-2 infection in the humanized ACE2 mouse model. ARDS-003 also outperformed an antiviral drug in reducing multiple proinflammatory mediators (i.e., cytokines) involved in hyperinflammation and immune system dysfunction following viral infection. Other studies have also demonstrated dose-dependent inhibition of viral replication.
 
Cellvera owns the rights to the brand originator Favipiravir, which has a long and verified history of safety and efficacy and was initially developed by FujiFilm Toyama Chemical Co and approved in Japan (2014) to treat pandemic influenza. Favipiravir is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. It targets the protein needed for the coronavirus to replicate, making it impossible for the virus to copy itself. The broad-spectrum antiviral drug is effective against 12 families of viruses, including Coronaviruses (COVID, MERS, SARS), Filoviruses (EBOLA, MARBURG), Flaviviruses (ZIKA, WEST NILE, DENGUE), RABIES, NOROVIRUS, and others. 
 
Preliminary studies on SARS-COV-2 Variants, Omicron and Delta, have shown that Favipiravir maintains its antiviral activity, demonstrating viruses’ inability to resist Favipiravir even with prolonged exposure of virus-infected cells to the drug. Clinical trials of Favipiravir have shown rapid viral clearance and prevention of hospitalization when administered early in the onset of the symptoms.
 
The parties hypothesize, based on data from AI based in-silico drug discovery platform Prepaire, that a combination product of Favipiravir and ARDS-003 has the potential to allow rapid virus clearance and provide longer-term patient benefits. ARDS-003’s cytokine reduction properties may prevent some consequences of SARS-CoV-2 infection, such as severe pulmonary inflammation.
 
Guy Chamberland, CEO and CRO at Tetra commented, “This partnership with a pharmaceutical company with global reach is a sign of the potential for the ARDS-003 drug asset.  We look forward to working jointly with Cellvera to bring this combination drug product forward to improve treatment options for patients worldwide.”
 
“The ongoing complexities of COVID-19 require multiple treatment options. By joining forces with Tetra, we hope to offer this additional treatment option to patients,” said Mary O’Brien, CEO of Cellvera. “This collaboration with Tetra supports our partnership strategy and the development of further combination therapies involving Qifenda (Favipiravir). We share a passion with Tetra to deliver innovative medicines to address this pandemic. We look forward to working with Guy and his team to investigate the potential of ARDS-003 and Qfienda (Favipiravir). By joining the Prepaire partner platform, we connect with like-minded experts from across industry, academia, and the government sector, we are better equipped to lead the way towards transforming drug discovery and development through the application of machine learning.”