Asthma Research & Clinical Trials
Asthma is a disease full of questions. It is a diverse disease that affects over 300 million people globally. It currently has no cure and no simple diagnostic test.
A model full of asthma research answers
At hVIVO we track our volunteers in a controlled environment from before infection, during infection and after recovery. Traditionally, participants are given a drug, sent home and from there you’ve lost the necessary and precise control of your trial.
With hVIVO, you’re able to mimic real life disease conditions, which means you’re greatly minimizing the variables and problems often associated with field studies and animal models. And since viruses trigger 80% of asthma exacerbations, the model provides a mechanism for studying IMP effectiveness across drug types and patient populations.
With cleaner information from the beginning, you’re empowered to make more informed decisions and move drugs through the development process more efficiently. Getting much more reliable results is the power of a controlled setting in our asthma challenge model.
Looking for more proof? Companies that have used our challenge model with a respiratory focus have experienced $2 billion in acquisitions. Please Contact Us for more information and to see if we can help your asthma therapeutic research programme.
Faster Answers. Proven Process
When hVIVO began working with respiratory syncytial virus (RSV), it was not a well‑understood disease. We defined and calibrated a disease model that has now become the gold standard. Two different landmark studies conducted by hVIVO with Alios and Gilead for RSV therapies were both published in the highly respected New England Journal of Medicine. In fact 3 out of 4 RSV therapies in development have utilised the hVIVO RSV model and challenge study in their clinical research plan. Given this success, we are using the same approach to develop new models for respiratory diseases, starting with asthma.
Studies using the hVIVO viral-induced asthma exacerbation model provide an alternative to move therapy from trial to product faster and better prepared than traditional studies. More than 80% of asthma attacks or exacerbations are caused by viruses, primarily cold viruses. The hVIVO platform enables us to observe these asthma attacks or exacerbations “in motion” and within a controlled setting, allowing you to benchmark your therapies faster and earlier than traditional research processes. It includes a proven process for dosing, infecting and analysing patient response across placebo and treatment groups to promote consistency across studies.
The hVIVO asthma disease model enables you to study asthma patients during the cycle of illness (ie: before, during and after exacerbation) to gain a complete picture of the process, better understand how your treatment works in humans and define the optimal dose – and, unlike field studies, you can find these answers and complete your study in months, not years.
How can we help accelerate your novel asthma therapy development?
hVIVO can help cut through the noise, longer timescales, greater unreliability and potential inaccuracy of field-based studies to help accelerate your novel asthma therapeutic faster and more reliably. We can:
- Validate assumptions regarding drug target, mechanism of action and biological impact in humans
- Confirm safety and efficacy
- Verify dosing regimens and accelerate time to market
The future of informed medicine is bright with hVIVO
Because the hVIVO platform addresses two of the key pain points in our industry – reliable pre‑discovery and fast and efficient clinical trials – we can add real value in a collaborative way. We can conduct targeted, more informed clinical trials for better decision making, reinvigorate existing drug assets with re‑profiling and repositioning, and support rational selection of future assets through hVIVO‑derived targets and biomarkers. With asthma, we have a commitment to continuous research learning and development.
hVIVO concluded its first ever asthma study in 2014
hVIVO announced the successful conclusion of its first ever asthma study seeking to develop a safe, reproducible and clinically relevant asthma human challenge model in December 2014. The Company self‑sponsored study provided the first commercially available viral challenge model for the study of asthma and antiviral therapies in asthmatic subjects. The model also produced the first samples obtained from subjects during the course of an asthma exacerbation using its hVIVO platform.
hVIVO released human model of viral-induced asthma exacerbation in 2015
hVIVO achieved a significant milestone with the official release of our human model of viral‑induced asthma exacerbation in 2015. With more than 80% of asthma exacerbations triggered by viruses, and around 2/3rd of this caused by Human Rhinovirus (HRV), hVIVO are superbly placed, with our own pharmaceutical grade (GMP) viral stocks, to use this virus as the catalyst to exacerbate asthma attacks in our controlled and state-of-the-art medical quarantine unit where we can monitor and study the whole process in mild to moderate asthmatics.
Volunteers monitored during entire disease cycle
The use of a human challenge model in a controlled environment permits volunteers to be studied during the cycle of illness (i.e., before during and after infection to gain a complete picture of the infection process). This enables each subject to provide their own internal baseline and allows interventions to be studied across the disease cycle. The development of these models will also permit the development of new diagnostics and companion biomarkers.
How can we help you in your asthma drug development pipeline?
Please Contact Us to find out more, to set up an exploratory meeting, or to see if a research collaboration with hVIVO may just help challenge the asthma “status quo” and help you to achieve better treatments, faster.
How We Do It
Our approach is different. By 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 or other therapeutic 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 and vaccine 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, RSV and asthma 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.
Interested in participating in a clinical trial?
Human volunteers are at the heart of all we do. Human Challenge Model 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 .