hVIVO (HVO) , a contract research organisation specialising in human challenge trials, noted an announcement by its customer Shionogi, reporting positive results from a Phase 2a Respiratory Syncytial Virus (RSV) human challenge trial conducted by hVIVO.
Shionogi said the trial demonstrated up to an 89% reduction in viral load for its investigational oral RSV antiviral, S-337395. The candidate, which holds Fast Track designation from the US FDA, was evaluated in a randomised, double-blind human challenge trial, recruited by hVIVO's specialised recruitment arm FluCamp. The antiviral efficacy and safety of S-337395 were evaluated when administered orally once daily over a 5-day period.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, commenting: "These results demonstrate the power of human challenge trials in accelerating the development of much-needed RSV treatments. The significant reduction in viral load and improvement in clinical symptoms observed with S-337395 demonstrate the potential of this antiviral candidate to address the urgent need for effective RSV therapies. At hVIVO, we are proud to leverage our decades of experience in human challenge trials to support innovative drug development, helping to bring promising new treatments to patients faster. We look forward to seeing continued success for Shionogi and S-337395 going forward."
View from Vox
hVIVO reports positive results from its Phase 2a RSV human challenge trial (HCT), testing Shionogi's oral candidate S-337395. In the study, the treatment group showed a significant reduction in viral load compared to the placebo group, with the highest-dose group showing an 89% reduction, alongside a significant improvement in clinical symptom scores. Additionally, S-337395 was shown to be safe and well-tolerated.
hVIVO has a strong track record of supporting the development of vaccine and antiviral candidates using its signature human challenge models. The company has over 3 decades of expertise in conducting HCTs for a range of respiratory viruses, including RSV, influenza, human rhinovirus (common cold), and Covid-19. HVO's trials are in high demand as they offer time-efficient and cost-effective ways to generate early human efficacy data and inform later-stage trial design, accelerating the path to market for new drugs.
In particular, hVIVO's RSV challenge model has been highly successful and pivotal to the development of multiple RSV antiviral and vaccine candidates. Including Shionogi's S-337395, HVO has conducted 30 RSV challenge trials to date involving c. 2,000 healthy volunteers. Most recently, HVO won an £11.5m contract with an existing top-tier pharma customer to test its RSV candidate.
HVO has issued FY25 revenue guidance of £73m, representing a significant uplift over FY24, with management projecting full-year EBITDA margins in the mid-high teens. Likewise for FY26, HVO has projected "strong growth in revenue and a significant improvement on EBITDA margin". As of September 10, 2024, the group had a pipeline of c. £40m, of which c. £15m had been converted into contracts, with c. £25m representing active opportunities. HVO is aiming for £100m of revenues by FY28, which is highly achievable given its strong sales momentum and £44.2m cash position.
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