Human Challenge Study Services in Drug Development
Capabilities & Benefits
With the evolution of increasingly more virulent viral diseases, increasing complexity of managing chronic diseases, and growing pressure to deliver safer, more effective treatments at a faster pace, current processes are no longer sufficient. You need to identify promising drugs sooner with higher confidence.
You need to understand the disease progression and human response in more detail earlier to improve drug development time, costs and efficiency, including trial design, dosing regimens, and safety profiles. Human challenge studies with hVIVO human disease models, or viral challenge studies, provide that insight so you can:
- Obtain superior clinical results
- Identify promising drugs faster
- Promote disease understanding and rational drug selection
- Obtain expert designed, efficient studies with on-time delivery
hVIVO currently offers viral challenge studies in healthy volunteers in influenza, human rhinovirus (HRV) and respiratory syncytial virus (RSV). The company is also developing virus challenge models in older volunteers (those over the age of 45) and models in diseased individuals with asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and other respiratory diseases where viral infections play a major role in the course and development of disease.
There are many benefits to the healthy and disease based model with these benefits being classified into key areas; regulatory benefits, non-clinical benefits, clinical benefits and program benefits.
- Exposure – response and safety information
- Pharmacological activity
- Efficacy assessment
- The conduct of viral challenge studies requires no additional safety reporting over non-virus challenge studies
Non-clinical animal models are very poor in respiratory diseases due to anatomical differences – e.g. mice have no lower respiratory tract smooth muscle – and the confounding differences such as the impact of smoking and pollution. This makes the use of animal models of airways disease unreliable, and as a consequence only two new classes of drug have been marketed in 30 years. The ability to conduct human models without additional requirements is therefore very important.
There are no additional toxicological requirements for the virus, so existing data packages will suffice.
Airways disease is multifactorial in humans. For example, the exacerbation of asthma is usually due to both a viral infection and an allergen. Therefore traditional allergen challenge models miss the complexities of airways disease and hence draw erratic conclusions. The use of a viral challenge model, particularly in an asthmatic or a COPD patient, mimics aspects of normal disease patterns and hence can provide a greater degree of precision about drug effects, reducing time to market.
The widespread acknowledgement of the problems with animal models and
traditional human provocation testing, leads to multiple cycles of incremental development. It also prevents biomarker development, as in order to find biomarkers that can assist in drug development, large trials are needed; but with a viral challenge the new drug or biomarker can be studied before infection, during infection and after infection,
making the development cycle more iterative and permitting the identification of new targets significantly simpler.
The conduct of human challenge models in both healthy and diseased populations provides several benefits in terms of:
- Reducing drug failures (and making failures fail early to allow research re-prioritisation)
- Providing valuable information to guide both drug development and program development
- Reducing time to market
- Identifying biomarkers to assist in stratified medicine
- The use of a viral challenge model, particularly in an asthmatic or a COPD patient, mimics aspects of normal disease patterns
How We Do It
In our human challenge studies, healthy volunteers are isolated in our specialist facility and are infected with a suitable respiratory virus, which is manufactured according to the highest pharmaceutical standards. They are then observed for 10 to 17 days typically. During this time, they may be treated with a new drug candidate, or may have already been given a new vaccine.
In addition, the Company often works on virus only research programmes with the intention of simply understanding how a virus and the human body interact with such research programmes holding the potential to lead to exciting new therapeutic discoveries.
The success of our approach relies on carefully selecting human volunteers and monitoring them throughout a disease episode under tightly controlled medical quarantine conditions. We can demonstrate proof of concept for a new investigational drug in a much shorter timeframe and in fewer subjects than traditionally, and crucially before investing in large, expensive field-based studies. hVIVO embraces the whole of our technology platform, from patient recruitment through to biomedical research and accelerated drug development.
Our hVIVO human models of disease utilise the ability of challenge agents, such as respiratory viruses, to elicit common self-limiting diseases such as flu, cold and RSV in otherwise healthy volunteers. By watching the entire disease lifecycle as subjects move from healthy to sick and recover back to healthy again, we can obtain high quality, longitudinal data from the before, during and after phases of disease. These models can be used to study the efficacy of new therapies such as antiviral drugs and vaccines and also to study the target disease itself.
“The advantages of a safe, reproducible human model are incalculable. This model permits the relatively quick and efficient study of new therapeutics in humans, and assists in making critical decisions.” American Journal of Respiratory and Critical Care Medicine, 2010
For more information on our viral challenge services, or to make a specific research or collaboration enquiry, please use the Contact Us form.
Interested in participating in a clinical trial?
Human volunteers are at the heart of all we do. Human challenge studies entail working either with healthy volunteers, or with patient volunteers who suffer with a specific illness or disease that we are targeting, for further exploration and much greater in-depth understanding.
‘FluCamp’ is a volunteer recruitment brand of hVIVO Services Limited.
To find out more about the whole volunteer experience in hVIVO ‘FluCamp’ clinical trials, the science behind it, and to register your interest in volunteering, visit our dedicated FluCamp volunteer information and recruitment site at www.flucamp.com