Firebrick completes recruitment for Phase 3 nasal spray trial, seeks to finally get TGA approval

Can you spray away the common cold? Pharma company Firebrick Pharma (ASX: FRE) says yes. After completing two clinical trials, the Company has entered Phase 3 trials for its Nasodine Nasal Spray, which has enrolled 500 patients to trial the product. 

The primary objective of the study is to assess the effectiveness of Nasodine compared to a placebo in reducing the severity of cold symptoms among individuals who have been confirmed positive for a respiratory virus (except Covid-19) through PCR testing. This particular set of participants is alluded to as the ITTi group (intention-to-treat-infected).

Expecting a gradual increase in the number of participants confirmed with viral infections, the Company estimates that the ITTi population will consist of at least 255 individuals, making up 50% of the total participant pool. This number surpasses the company’s initial target of 196 participants for the ITTi group by 130%.

Executive Chairman of Firebrick, Dr Peter Molloy, said, “Subject to availability of the complete efficacy data and timely completion of the statistical analysis, we expect to report headline results of the trial by the end of September.” 

Firebrick is not the only company in the nasal spray-can-fix-a-cold market. Biopharmaceutical company Starpharma (ASX: SPL) also has an antiviral nasal spray product, VIRALEZE, to address respiratory viruses, including Covid (for which it is conducting a post-market clinical study). VIRALEZE is approved in Malaysia, Singapore, Europe, Hong Kong and more. 

Last week, Firebrick reported that its Phase 2 trial of Nasodine for Covid-19 has achieved its primary endpoint, which was to reduce the viral load in four days. The treatment ran over two and a half days and on the fourth day, 100% of the Nasodine subjects were clear of virus. Currently, however, it has only conducted this study in a small group of 39 subjects in South Africa.

The Company has no intentions of pursuing the Covid-19 route or even seek regulatory approval for it. It just conducted a small trial in case Covid returns. 

As of 30 June 2023, Firebrick held cash and cash equivalents of $2.35 million, compared with $3.44 million at the end of the March quarter. Net cash outflow from operations for the quarter stood at $2.08 million, 66.8% of which was for R&D expenditure associated with the two clinical trials being undertaken by the Company. Firebrick expects the R&D rebate to make up for its expenses.

Moreover, in the June quarter, the Company continued with its appeal to the Administrative Appeals Tribunal (AAT). The appeal seeks to overturn the TGA (Therapeutic Goods of Australia)’s decision not to approve Nasodine for sale in Australia. The TGA wanted more proof that the nasal spray works, and the Company plans on using its Phase 3 trial data to make its case. 

A goal of the Phase 3 clinical trial is to gather the essential information required for Nasodine’s approval in Europe and to foster international partnerships for Nasodine. The Company intends to submit the registration paperwork to the European Union (EU) by January 2024, and it is confident in its ability to meet this projected schedule.