GCIhVIVO's study reveals strong efficacy of Enanta's RSV candidate EDP-323
() , a contract research organisation specialising in human challenge trials, noted positive results from its Phase 2a respiratory syncytial virus (RSV) trial conducted for Enanta's EDP-323 antiviral candidate.
Enanta's EDP-323 is an oral direct-acting antiviral in development for RSV infection, which has progressed rapidly since receiving US FDA Fast Track designation. The results from 's human challenge trial, involving 142 healthy adults, successfully demonstrated the effectiveness of EDP-323.
Participants were split into 3 cohorts of equal size - one receiving a high dose, one receiving a low dose, and one receiving placebo. The results showed that EDP-323 was safe, well-tolerated, and had a rapid and sustained antiviral effect.
Specifically, the results showed an 85-87% reduction in viral load AUC by qRT-PCR, a 97-98% reduction in infectious viral load AUC by viral culture, and a 66-78% reduction of total clinical symptoms score AUC compared to placebo.
Dr Andrew Catchpole, CSO of hVIVO, commenting: "Enanta's trial demonstrates the depth of actionable insights a comprehensive human challenge trial can provide. We congratulate Enanta on these impressive results, which mark a significant step forward in the development of new medicines to treat respiratory infections such as RSV. Achieving such positive outcomes underscores the potential of this novel RSV treatment to make a meaningful impact on patient care. We are proud to provide world leading human challenge trials to support the development of exciting drug candidates which hold the potential to have a positive impact on global health."
View from Vox
More good news from hVIVO as the HTO specialist announces positive results from its large RSV antiviral trial for EDP-323, an antiviral candidate being developed by Enanta with FDA Fast Track designation. EDP-323 is Enanta's second RSV candidate after Zelicapavir (EDP-938), which demonstrated impressive results in an earlier RSV HCT, and is in later-stage clinical development.
hVIVO's study definitively demonstrated the efficacy of EDP-323, while also showcasing the power and cost-effectiveness of human challenge trials in accelerating data collection for drug development. Demand remains high for hVIVO's growing portfolio of HTOs, offering its biopharma clients key advantages that streamline and accelerate their later-stage trials. hVIVO's pipeline includes a range of antiviral candidates, such as RSV, influenza, human rhinovirus (common cold), and Covid-19.
hVIVO maintained a strong orderbook of £71m at the end of H1 2024, with 100% of FY24 revenue guidance already contracted, giving full visibility for FY24 as well as excellent visibility for FY25. Sales momentum should accelerate with the launch of 's standalone virology and immunology lab services out of its newly acquired CL-3 facility at Canary Wharf. The facility is the world's largest commercial human challenge trial unit, and is expected to significantly diversify 's pipeline with new pathogen models.
hVIVO maintains a full-year revenue guidance of £62m, with management projecting full-year EBITDA margins to be at the upper end of market expectations on the basis of strong performance in H1 and full visibility for the remainder of the year. The group has a significant pipeline that is continuing to grow, including new challenge models and new revenue streams (eg clinical site studies, standalone lab services, and volunteer/patient recruitment), having short-to-medium term value of c. £40m. hVIVO aims for £100m of revenues by FY28, which is highly achievable given its strong sales momentum and US$37m cash position.
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