hVIVO plc (LON:HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that its Omicron human challenge agent has been successfully manufactured.
Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, this has expanded the Company’s unique portfolio to 11 human challenge models to test a broad range of infectious and respiratory disease products. hVIVO actively offers Omicron human challenge trials as part of its service offering and is currently in discussions with a number of existing and potential customers.
As announced on 30 June 2022, the model was developed with Vaxart Inc., (NASDAQ: VXRT) with the intent to conduct a subsequent Omicron human challenge study to test the efficacy of Vaxart’s oral vaccine candidate. The Company notes the announcement from Vaxart and its decision to postpone further clinical trials in its COVID-19 programme, including the challenge study, as they focus upon the development of an oral pan-betacoronavirus vaccine, which may provide improved protection against SARS-CoV-2 as the virus continues to mutate and protection against other types of betacoronaviruses.
The Vaxart challenge study was not included in the Company’s order book and its postponement will have no impact on hVIVO’s 2023 financial guidance. As at 31 December 2022 the Company’s orderbook was £76m, with over 95% of forecasted revenue for 2023 contracted.