COVID-19 R&D PROGRAMS
Repurposed COVID-19 Drugs are Desirable Because they have Documented Safety
Balinbac repurposed drugs are either FDA cleared & marketed or IND approved. The safety pharmacology profiles are known and toxicology studies have been completed to establish dosing safety margins.
Safer equals faster as minimal or no additional work may be needed to treat people in large expanded access trial settings.
The time to availability for patients in registration trials and pandemic treatment studies are minimized.
Repurposed Drugs for
COVID-19 are Accessible
Chemistry, manufacturing & controls are established and approved. Therefore, the scale up of active pharmaceutical ingredients (API) can be done rapidly and in bulk for mass treatment.
Drug product manufacturing can be scaled quickly for existing & new dosage forms as a regulatory priority.
Distribution supply chain in wholesaler and pharmacies are already in place and prescribing physicians are already familiar with these drugs.
Repurposed Drugs Need
In-Vitro Testing Results to Trigger Rapid Development
COVID-19 antiviral activity testing is gate keeping to initiate development.
Acceptable antiviral activity and safety margins must be reconfirmed.
BalinBac has conducted these studies in human lung cells (CALU-3).
Balinbac BB-700 series for COVID-19 Drug Treatment Will Resemble HIV Antiviral Products that Incorporate Multiple Mechanisms of Action into Single Formulations
HIV Example: Individual drug with two mechanism and multi-drug regimen; 1) Atripla (Efavirenz [NRTI]/emtricitabine [NNRTI]/tenofovir disoproxil [NRTI], 2) Atripla is drug with components with two mechanism of action (MOAs), 3) Atripla (NRTI/NNRTI) + Ritonavir (PI) + Lopinavir (PI).
COVID-19 will evolve multi-MOA drugs & regimens for more opportunities to shut down viral replication & related super-infections that cause sepsis
Example: NYS Trials of Hydroxychloroquine (MRI) + Azithromycin (Antibacterial Macrolide)
Six Antiviral Mechanisms Hold Promise, When Used in Combination, for COVID-19
Phosphatidylserine Modulators (PSMs)
Entry Attachment Inhibitors (EAIs)
Protease Inhibitors (PIs)
RNA-dependent RNA polymerase Inhibitors (RdRpIs)
MicroRNA Inhibitors (MRIs)
Endosome Acidifiers (EAs)