Tetra Bio-Pharma Inc., a leader in cannabinoid-derived drug discovery and development announced they signed an agreement with Cellvera Global Holdings LLC (“Cellvera”), 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.
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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 many others.
As novel strains of the SARS-CoV-2 virus continue to emerge, 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. Favipiravir remains an invaluable asset for emergency preparedness strategies against this constantly evolving COVID-19 virus and other potential future pandemics. 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.