PrEP Biopharm Limited, a private drug company developing treatments for respiratory infectious diseases, announced that it has successfully completed a 12-week toxicology study in dogs. There were no mortalities and no test item-related changes in clinical signs, body weights, food consumption, or other systemic nor macroscopic adverse effects at doses up to 15 mg/day (highest dose level tested). 

The study provided necessary and reassuring safety data to move PrEP-001 into longer duration dosing in clinical studies. The company intends to move forward with areal-world, field trial intended to validate the efficacy of its PrEP-001 against all circulating respiratory viruses (including COVID-19, influenza, and the common cold).

Founded in 2015 as a spinout from Johnson & Johnson, PrEP Biopharm Limited has conducted pre-clinical and proof of concept clinical studies that have shown positive efficacy in humans. The proof of concept challenge studies involving short-duration dosing in human subjects demonstrated positive safety and efficacy results specifically for influenza and rhinovirus (the most common viral infectious agent in humans that is the predominant cause of the common cold). In other animal model challenge studies, positive data was shown for SARS, MERS, RSV, and a variety of other respiratory viruses that cannot ethically be assessed in human challenge studies.

PrEP-001 (Poly I:C) is neither a vaccine nor an antiviral. Rather, it is a synthetic RNA 'viral mimic' that stimulates the body's pan-viral innate immune response locally in the upper respiratory tract. Administered via a once-daily nasal spray it leverages the innate immune system to create an antiviral environment to stop invading respiratory viruses. As such, it is possible that PrEP-001 could be used as stand-alone pan-viral prophylaxis or as an adjuvant for live and inactivated or peptide intranasal vaccines targeting specific respiratory viruses.

Previous studies in animals have demonstrated that intranasal administration of poly IC shortly after vaccination with live-attenuated, inactivated and haemagglutinin antigen preparations of influenza virus enhanced respiratory dendritic cell function, CD8 T cell formation, and production of neutralizing antibodies.

The proposed field trial will provide real-world data as stand-alone prophylaxis against influenza, the common cold, COVID-19, and other respiratory viral illnesses.

"We are excited about these new data allowing us to dose PrEP-001 daily for up to 12 weeks which is the expected length of a typical cold & flu season. We intend to move forward with a field trial to assess the efficacy against a number of common respiratory viruses and provide real-world validation of PrEP-001 as a novel pan-viral prophylaxis," said Ryan Muldoon, CEO of PrEP Biopharm Limited.

Influenza and rhinovirus market opportunities alone are enormous. But PrEP-001 could also play a meaningful role in the current COVID-19 pandemic and future pandemics with other novel respiratory viruses.