A 12-week clinical trial into the first new cough drug for 50 years is to be carried out in the UK, it has been announced.
The trial will be led by the National Institute for Health Research.
If approved, the drug, AF-219, would be the first new cough drug in half a century and would offer new hope to the millions of people who have a chronic cough and do not have any effective treatment for it.
NIHR Translational Research Partnership (TRP) is testing AF-219, which was developed in the USA by Afferent Pharmaceuticals, as part of a 12-week clinical trial involving 200 patients at 47 sites in the UK and US.
AF-219 selectively blocks P2X3 receptors and stops the mechanism by which certain airway nerves become hyper-sensitised. A proof-of-concept study, involving 24 people, showed that those taking AF-219 reduced the number of times they coughed by 75% compared to placebo.
The NIHR TRP trial will use a cough monitor that was developed by Professor Jaclyn Smith, of the Centre of Respiratory and Allergy at the University of Manchester, with UK ME Vitalograph, supported by the NIHR South Manchester respiratory and allergy clinical research facility.
The VitaloJAK works by recording the cough sounds and allows the number of coughs in a 24-hour period to be counted and the effects of new therapies to be objectively quantified.
Prof Smith said: “We are just beginning to understand how the nerves in the airways are involved in pathologic cough such as chronic cough. With recent developments in the technology to effectively measure coughs and this important new drug, we have started to see real progress in this area.”
The trial is the first commercial clinical trial in the UK to use the Health Research Authority’s new approval system.
Patient recruitment is due to complete in the next two months.
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