Human challenge studies are an increasingly accepted approach for obtaining initial clinical proof-of-concept for novel drug and vaccine candidates, especially in the context of tackling viral disease and the need to obtain early indications of efficacy prior to embarking on costly field-based clinical trials.
The potential benefits of human challenge studies:
- Early human proof-of-concept efficacy data to support drug and vaccine candidate selection
- Support accelerated development of pipeline compounds, through early identification of the appropriate endpoints, dose response and timing and biomarkers for incorporation in later clinical studies
- Reduced costs as the model requires a relatively small number of subjects investigated over a shorter period of time to deliver and efficacy outcome
hVIVO has particular expertise in conducting human challenge studies using influenza (flu), human rhinovirus (HRV) and respiratory syncytial virus (RSV) for pharmaceutical and biotech companies.
We have been conducting viral challenge studies for over 15 years, initially using cold and flu viruses and more recently adding RSV. We remain the only company to have a validated RSV challenge model commercially available to customers.
We believe the challenge model is not only helpful as a proof-of-concept for the effectiveness of agents directed at viruses, but also as proof-of-mechanism for novel products in diseases where respiratory viruses are known to induce exacerbations. hVIVO is expanding its offering into airways diseases such as asthma, cough and COPD, and these expanded service offerings have the potential to provide the Company with valuable additional revenue streams.