Australian pharmaceutical company Firebrick Pharma has announced the initiation of a Phase 2 trial of its Nasodine povidone-iodine nasal spray for the reduction of viral shedding in patients with COVID-19. According to Firebrick, a 2001 pilot study with 6 COVID-19 patients demonstrated that a single dose of Nasodine reduced viral shedding by almost 80% one hour post dose. The Phase 2 trial will evaluate the effect of dosing 144 patients up to 8 times per day over 3 days.
In addition to the COVID-19 studies, the company says, it has completed a Phase 3 trial of the nasal spray for treatment of the common cold and is planning a second Phase 3 trial for that indication. The TGA has already declined to approve Nasodine based on currently available data, a decision that Firebrick is appealing.
Firebrick Executive Chairman Peter Molloy said, “If the trial demonstrates that the Nasodine regimen reduces or eliminates viral shedding, it could point to a potentially important role for Nasodine treatment in anyone who has been recently diagnosed with COVID-19. While secondary to our focus on the common cold, this Phase 2 COVID-19 trial is important because it may provide proof-of-principle for the reduction of SARS-CoV-2 nasal viral load in patients who are shedding the virus. Demonstrating that an agent kills a virus in the laboratory is one thing; proving that it translates clinically is a big step, which we are now taking.”
Read the Firebrick Pharma press release.