hVIVO (HVO) has signed a Clinical Trial Agreement with Traws Pharma to conduct a Phase 2a human challenge trial evaluating its antiviral candidate tivoxavir marboxil for influenza.
Watch: hVIVO Lands Influenza Trial Deal
The randomised, double-blinded, placebo-controlled study will take place at hVIVO’s quarantine facilities in Canary Wharf. It will assess the safety, tolerability and effectiveness of the single-dose oral treatment in reducing influenza-related illness in about 150 healthy participants.
The trial is expected to begin in the first half of 2026, with most of the revenue recognised during the year. Recruitment will be handled by hVIVO’s FluCamp platform, while laboratory work will be conducted at its specialist virology lab, supporting a fully integrated delivery model.
Tivoxavir marboxil is being developed as a prophylactic antiviral targeting both seasonal influenza and bird flu. The programme aims to demonstrate efficacy more rapidly than traditional field studies using hVIVO’s established influenza human challenge model.
Influenza remains a major global health burden, causing about 1 billion cases annually and up to 650,000 deaths. hVIVO has previously conducted more than 2,400 human challenge trials across influenza, respiratory syncytial virus and other respiratory viruses, dosing over 5,000 participants.
hVIVO’s Chief Executive Officer Yamin 'Mo' Khan said: “Through our Influenza Human Challenge Trial Model, we will be able to deliver fast, controlled, high-quality efficacy data for Traws Pharma that would not be achievable in traditional field studies, reducing development risk for TXM and improving capital efficiency. By leveraging key synergies across our integrated clinical development services and conducting participant recruitment all under one roof, this trial illustrates our unique value proposition as a true full-service clinical development partner.”
Traws Pharma’s Chief Executive Officer Iain D. Dukes said: “This agreement represents an important step forward for Traws as we advance our programme and seek to generate high-quality, efficacy clinical data efficiently. Partnering with hVIVO enables us to leverage a proven human challenge platform to support our development strategy and accelerate progress towards our next value-inflection point.”
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This contract highlights continued demand for hVIVO’s human challenge model, particularly in respiratory diseases where speed and data quality are critical. The fully integrated approach - combining recruitment, quarantine and laboratory capabilities - remains a key differentiator, supporting repeat business and new partnerships.
With revenue expected to land largely in 2026, the agreement also adds near-term visibility. More broadly, as antiviral development accelerates post-pandemic, hVIVO appears well positioned to benefit from increased R&D activity in infectious diseases.