hVIVO (HVO ), a specialist contract research organisation, noted an announcement by Cidara Therapeutics regarding positive interim results from hVIVO's ongoing human challenge study testing Cidara's CD338 antiviral candidate for seasonal influenza.
CD388 is Cidara's long-acting drug-Fc conjugate antiviral for the treatment of seasonal influenza. The interim analysis showed a decrease in viral replication in the upper upper respiratory tract and influenza infection in participants receiving a single dose of CD388 when compared to placebo.
hVIVO is conducting the Phase 2a double-blinded trial using its H3N2 influenza human challenge study model.
Cidara said CD388 was "well-tolerated with no drug-related adverse events observed".
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, noted: "...the data underlined the potential of Cidara's Cloudbreak drug-Fc conjugates, of which CD388 is one example, to be efficacious long-acting therapeutics with universal protection of seasonal and pandemic influenza."
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The interim results from hVIVO's study of Cidara's CD388 candidate establish a preliminary proof of concept for CD338's efficacy against H3N2 influenza, and basis for CD338's ongoing development programme.
The results are another clear demonstration of the value of human challenge studies. Such studies provide great value for biopharma companies as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 trials. This gives companies the best possible chance of quickly advancing their candidates through the development pathway.
hVIVO now boasts 11 human challenge study models and has become a go-to partner for big pharma and biotech clients. Four of the top ten global biopharma companies are now regular clients of hVIVO. The company's orderbook continues to grow, standing at £76m on 31 December 2022, up 60% year-on-year.
In 2023 so far, hVIVO has won a £5.2m contract to test an RSV vaccine, a €3.2m consultancy contract, and a £6.8m RSV contract with an Asia Pacific (APAC) client - the second APAC contract for the company. hVIVO now has 95% of forecast revenue for 2023 with strong visibility into 2024.
We expect hVIVO to meet or exceed FY23 market forecasts, with today's announcement further strengthening its revenue visibility into 2024.
HVO shares gained 2.74% on the news.
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