Nasodine Phase 2 COVID-19 Trial Results Published

  02 Apr 2024

HIGHLIGHTS

  • Nasodine Phase 2 COVID-19 trial details and results published in prestigious peer-reviewed journal
  • Results support Nasodine as a nasal antiseptic/disinfectant.

Firebrick Pharma (ASX:FRE) is pleased to announce that its Phase 2 COVID-19 trial has now been published in the journal, Laryngoscope, which is a high impact journal highly ranked in the field of otolaryngology.

The paper titled “Phase II Trial of the Impact of 0.5% Povidone-Iodine Nasal Spray (Nasodine®) on Shedding of SARS-CoV-2” is available online.

Headline results of this trial were previously reported by Firebrick (announcement 7 August 2023), highlighting that the trial achieved its primary endpoint with Nasodine treatment significantly reducing the nasal viral load of SARS-CoV-2.

Importantly, Nasodine treatment also led to 100% clearance of the virus from the nose after completion of treatment. The published paper concluded:

“The Phase II data demonstrate that frequent dosing with a 0.5% PVP-I intranasal formulation (Nasodine) can reduce the titers of culturable SARS-CoV-2 virus recovered from a subject’s upper respiratory tract. Nasodine is the only PVP-I nasal spray that has been manufactured at scale in accordance with GMP, with established stability, and with proven safety and tolerability in multiple human clinical trials. It is therefore amenable to rapid deployment as a readily administered intervention in the face of emergent pandemic/epidemic respiratory threats such as COVID-19.”

This published paper is an important endorsement of the quality and significance of the trial.

The demonstrated reduction in viral load and 100% clearance of an important respiratory virus should be highly supportive of the potential for Nasodine as a nasal antiseptic/disinfectant.

As noted in the Company’s half-year report (announcement 28 February 2024, page 2): “the Company expects that Nasodine can be legally marketed in several countries (outside Australia) as a nasal antiseptic/disinfectant without further clinical studies or new regulatory approvals.

The Company is now advanced in our plans to introduce Nasodine in at least one international market, with sales expected to commence in the first half of 2024.