Open Orphan PLC (ORPH.L) Successful completion of toxicology study

Successful completion of PrEP Biopharm Toxicology study for respiratory ‘viral mimic’

Phase IIb study to validate efficacy of PrEP-001 against

circulating respiratory viruses such as COVID-19, flu and the common cold

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces that drug development company PrEP Biopharm Limited (“PrEP Biopharm”), which is 62.6% owned by Open Orphan, has successfully completed a 12-week toxicology study for its novel pan-viral prophylactic asset, PrEP-001.

The animal model study provides safety data needed to move PrEP-001 into longer duration dosing in clinical studies. PrEP Biopharm intends to move forward with a real-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.

PrEP-001 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 a 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 neutralising antibodies.

When Open Orphan acquired hVIVO in January 2020, in addition to acquiring the world leader in the testing of vaccines and antivirals using human challenge studies, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm. The previous hVIVO Board had used shareholders’ funds to invest in these non-core assets. The Open Orphan Board and management team are primarily focussed upon cementing its position as a unique CRO and is committed to directing all resources to further improving the quality of earnings in both Venn Life Sciences and hVIVO and with shareholder funds only being used to support the profitable CRO services business. In recent months, Open Orphan has made it clear that it intends to monetise these non-core assets, however, as part of monetising these non-core assets, Open Orphan does not intend to invest any of the Open Orphan shareholders’ funds but will continue to work with the PrEP Biopharm management team to secure other sources of funding outside of the Open Orphan group while maximising the potential of these non-core assets.

Cathal Friel, Executive Chairman of Open Orphan, said: “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.”

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