Inhaled interferon ß ('IFN-ß') for the treatment or prevention of COPD exacerbations caused by the common cold

Chronic Obstructive Pulmonary Disease (COPD), which comprises chronic bronchitis and emphysema, is predominantly caused by smoking. It is the third leading cause of death worldwide and is an area of significant unmet clinical need. Up to 60% of all COPD exacerbations (worsening of COPD symptoms) are preceded by common cold infections. The common cold (predominantly caused by rhinovirus, but also by coronavirus, respiratory syncytial virus and parainfluenza virus) is a major factor contributing to the exacerbations; for example, if a COPD patient catches a cold, there is a 50% chance that it will lead to an exacerbation of their disease1. Many exacerbating COPD patients will be hospitalised, with associated health economic consequences. 15% of COPD patients admitted to hospital die within three months and 25% die within a year of admission2. Currently there are no satisfactory treatments available to address this significant unmet need.

Background

  • COPD lung cells are more susceptible to common cold virus infections compared to cells from non-smoking control volunteers
  • Low levels of IFN-ß protect COPD lung cells from the common cold virus infection (Refer to Figure 1 below)
  • This data provides a rationale for developing inhaled IFN-ß to prevent or treat common cold induced exacerbations of COPD
  • Intellectual property (patents) was exclusively in-licensed from the University of Southampton to protect this development programme. The patent was granted in the USA (August 2009), Europe (May 2010) and Japan (July 2011)

undefined

Figure 1: In vitro exogenous IFN-ß restores antiviral defences in COPD lung cells

Next steps

In April 2017, AstraZeneca handed back the rights of the inhaled IFN-β programme to Synairgen. Synairgen is awaiting full data analysis before making a decision on the future of the programme

COPD statistics

  • COPD is the 3rd leading cause of death worldwide (after heart attack and stroke)2
  • US national medical costs attributable to COPD and its consequences were estimated at $32 billion in 2010 and are forecast to increase to $49 billion in 20203
  • 12 million adults in the USA have reported a physician diagnosis of COPD and it is estimated that another 12 million may have COPD but do not realise it4
  • In 2010 there were 715,000 hospitalisations for COPD in the USA5
  • Research by the SUPPORT investigators estimated the average cost of a hospitalisation for a severe COPD patient to be $7,1006

References

  1. Hurst JR, Donaldson GC, Wilkinson TM, Perera WR, Wedzicha JA. Epidemiological relationships between the common cold and exacerbation frequency in COPD. Eur Respir J. 2005 Nov;26(5):846-52
  2. Consultation on a strategy for chronic obstructive pulmonary disease (COPD) in England. Available at http://www.dh.gov.uk
  3. World Health Organisation. Available at http://www.who.int/mediacentre/factsheets/fs310/en/
  4. Earl S et al. Total and State-Specific Medical and Absenteeism Costs of COPD Among Adults Aged = 18 Years in the United States for 2010 and Projections Through 2020. Chest. 2015;147(1):31-45
  5. US National Heart Lung and Blood Institute. Available at http://www.nhlbi.nih.gov/health/public/lung/copd/index.htm
  6. American Lung Association: Trends in COPD (chronic bronchitis and emphysema): Morbidity and Mortality. March 2013. Available at http://www.lung.org/finding-cures/our-research/trend-reports/copd-trend-report.pdf
  7. Connors AF Jr et al. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators. Am J Respir Crit Care Med 1996;154:959-967.