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Trial Underway Testing Drug to Reduce Chronic Cough

CT scan of lungs with IPF

High-resolution CT scan of lungs with idiopathic pulmonary fibrosis (IPF Editor, Wikimedia Commons)

14 June 2016. A clinical trial testing a drug treating chronic cough — coughs continuing for 8 weeks or more — will begin recruiting participants in the U.K. to join other sites in the U.S. The U.K. sites are under the direction of National Institute for Health Research, testing a  small molecule, or low molecular weight, compound code-named AF-219, developed by biotechnology company Afferent Pharmaceuticals in San Mateo, California.

Chronic cough is condition where an upper respiratory disease causes a cough lasting a few weeks, but the nerve fibers remain irritated and fail to return to their normal state, causing a coughing reflex. The same mechanism, says Afferent, may be at work in disorders such as idiopathic pulmonary fibrosis or whooping cough, where non-productive coughing serves no useful purpose.

AF-219 is Afferent’s lead product, designed to address proteins known as P2X3 receptors that overproduce in nerve fibers when hyper-sensitized, involving in this case nerve fibers in lung tissue. The company says chronic cough may affect as many as 10 percent of the population, particularly among people with lung disorders that do not respond to treatments directly addressing those conditions. Afferent is also developing drugs targeting P2X3 receptors involved in chronic pain, cardiovascular diseases, and other disorders.

The company conducted a proof-of-concept trial with 24 individuals in the U.K. having persistent chronic cough, testing AF-219 against a placebo. The results, reported in The Lancet, show participants receiving AF-219 in tablets twice a day reduced their cough frequency by 75 percent.

The new clinical trial is recruiting 200 individuals in the U.S. and U.K., testing AF-219 at 3 dosage levels against a placebo for 12 weeks. The U.K. site is in Manchester, under the direction of University of Manchester medical school professor Jaclyn Smith, who led the proof-of-concept study. Smith is also an inventor of the VitaloJAK, a wearable medical device that records cough frequency without audio or video recordings, also used in this trial.

“Previously, studies relied on patient reported outcomes, which are not always reliable,” says Smith in a National Institute for Health Research statement. “This may lead to effective drugs being dismissed due to inaccurate reporting and, I believe, is a contributing factor to the lack of interest from big pharma companies in investigating new cough treatments.”

Smith adds, “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.”

Last week, the pharmaceutical company Merck agreed to buy Afferent Pharmaceuticals for $500 million in cash, and another $750 million in milestone payments, connected in part to the development and commercialization of AF-219.

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