Open Orphan PLC (LON:ORPH) said PrEP Biopharm Limited, in which it owns a 62.6% stake, has completed a 12-week toxicology study for its novel pan-viral prophylactic asset, PrEP-001.
The pharma services firm said the animal model study provides safety data needed to move PrEP-001 into longer duration dosing in clinical studies, adding that PrEP Biopharm intends to move forward with a real-world, field trial that is aiming to validate the efficacy of PrEP-001 against all circulating respiratory viruses including coronavirus (COVID-19), influenza and the common cold.
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PrEP-001 is a synthetic RNA ‘viral mimic’ which is designed to stimulate the body's innate immune response in the upper respiratory tract to stop respiratory viruses. The treatment candidate is designed to be administered via a once-daily nasal spray.
Open Orphan also said that it does not intend to invest any of its shareholders’ funds into the project but is instead working with the PrEP Biopharm management team to secure other sources of funding outside of the Open Orphan group.
"It is very encouraging to note PrEP Biopharm's progress towards the ultimate goal of validating the effectiveness of their one dosage nasal spray for key respiratory viruses like COVID-19, flu and the common cold. This safety data allows them to move into Phase 2b field studies and we are very excited that PrEP-001 could play a meaningful role in the current COVID-19 pandemic and future potential pandemics caused by new respiratory viruses", Open Orphan executive chairman Cathal Friel said in a statement.