03 Apr 2023
- Recruitment has closed in the Nasodine COVID-19 Phase 2 Trial
- Trial results expected to be announced in June 2023
Firebrick Pharma is pleased to announce that its Phase 2 COVID-19 trial of Nasodine® Nasal Spray has closed for recruitment.
Nasal swabs collected from all subjects have been forwarded to a specialist virology laboratory in the Netherlands for viral culture analysis, which will determine the results on the trial’s primary endpoint. These results are expected to be available in June 2023.
The trial (designated FBP-007) commenced in April 2022 at five clinical sites in South Africa (see ASX announcement 26 April 2022). The study is a randomised, controlled Phase 2 study to assess the extent to which frequent daily Nasodine application can stop or reduce shedding of the COVID 19 virus (SARS-CoV-2) in patients with early COVID-19 symptoms.
The protocol involved application of Nasodine (or a placebo nasal spray) 8 times daily over 2.5 days (to a total of 20 doses). This compares with the 4 times daily over 5 days regimen used in the common cold clinical trials conducted by Firebrick to date.
“This frequent dosing was designed to definitively assess the potential for Nasodine to rapidly eliminate the SARS-CoV-2 virus from the nose, which is believed to be the primary site of infection and shedding,” said Firebrick Executive Chairman, Dr Peter Molloy.
“In addition, we hope the study results will support the safe use of more frequent dosing of Nasodine.”
The trial was originally intended to enrol up to 210 subjects but has been abridged to 39 subjects due to the ongoing very low numbers of new cases of COVID-19 in South Africa.
“We are confident that the reduced number of subjects will not impact our ability to detect statistically robust outcomes on the primary and secondary endpoints,” said Dr Molloy.
“COVID-19 will not be the last viral pandemic we face,” said Dr Molloy. “If the trial results are
positive, Nasodine could be at the front line of future pandemic defence strategies.”
The Company owns an international patent application covering the use of intranasal povidone-iodine for a range of pandemic viral diseases, including COVID-19. The COVID-19 divisional of this patent has been granted in the US and is pending in other key markets (see ASX announcement 17 February 2022).
The patent is titled “Prevention of infection by highly pathogenic viruses using topical application of povidone-iodine on mucous membranes” and expires in 2040 (Patent No. US 11,246,887).
The main use protected by the US patent is the use of any povidone-iodine formulation in the nose for reducing the viral load of SARS-CoV-2 in people with COVID-19 and it is particularly aimed at healthcare workers involved in front-line pandemic defence roles.
“The results of the Phase 2 trial are very pertinent to this patent since the primary endpoint is to demonstrate reduction or elimination of nasal shedding of the SARS-CoV-2 virus,” added Dr Molloy.
Other pandemic viral diseases applied for in the international patent, but not yet granted, include MERS, Ebola, pandemic influenza and any future emergent viruses (of as yet unknown origin and identity) that could cause a pandemic or be used as a bioterror agent.