hVIVO PLC (AIM:HVO), the clinical development company specialising in human challenge trials, has signed a consultancy contract with Decoy Therapeutics to support the development of a novel class of broad-spectrum respiratory antivirals.
The engagement covers translational modelling, regulatory strategy, chemistry, manufacturing and controls consulting, non-clinical development support, and preparation of clinical and regulatory documentation for submissions to European and UK regulators, including the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency.
Decoy is developing what it calls Designable Multi-Antiviral, or D-MAV, candidates, a new therapeutic category designed to target shared mechanisms across multiple respiratory viruses using a single adaptable drug, rather than developing a separate treatment for each pathogen.
The consultancy is structured to support first-in-human dose selection and translational pharmacology planning, with Decoy intending to progress to Phase I and human proof-of-concept studies, subject to securing additional financing and successful programme development.
Should those milestones be reached, Decoy has indicated it expects to conduct early proof-of-concept and follow-on studies with hVIVO, given the company's established track record in human challenge trials, where healthy volunteers are deliberately exposed to a pathogen in a controlled environment to test a drug's efficacy.
The deal illustrates a broadening of hVIVO's commercial model beyond the conduct of clinical trials into upstream advisory and regulatory services, with the company positioning itself as an integrated partner capable of supporting clients from preclinical planning through to proof-of-concept data generation.