Viral infections are reportedly responsible for approximately 65-80% of asthma and 40% of COPD exacerbations and occur despite appropriate treatments including inhaled corticosteroids (ICS). Recent evidence suggests, particularly in asthma, that allergic airway inflammation driven by TH2 cytokines is induced in the airway during human rhinovirus “HRV” related symptom worsening; with suppressed anti-viral immunity linked to exacerbation severity.
We can help with respiratory human challenge in both asthma and chronic obstructive pulmonary disease (COPD).
Human challenge models have, for many decades, enabled early proof of concept studies to include evaluable efficacy endpoints that can inform subsequent field trials. For many respiratory diseases, exacerbations are the key drivers of patient morbidity, mortality and increased healthcare costs; and therefore, remains a crucial target in the development of new and novel therapies. We have been at the forefront of human challenge models for over 15 years and can offer a suite of challenge models that can expedite and inform clinical development.
Conceptual Overview/Challenge: Immunoglobulins can target the host or the virus itself. A precise approach matching the drug MoA, patient population and study design, including selection of appropriate endpoints in an established viral challenge model is central to maximising trial success.
Utilising Our Challenge Models
The concept of human challenge models has been recognised for many years in the field of anti-inflammatory drug development.
Bronchial allergen challenge is a well-established model with decades of data supporting its use for confirming specific efficacy of anti-inflammatory as add on therapies in allergic asthma and related exacerbations.
The viral exacerbation challenge has been studied extensively over the last 30 years with potential for evaluating the effect anti-inflammatories can have on virally induced exacerbations.
Utilising Our Challenge Models
