IPF Patients with Chronic Cough Sought for Phase 2 Clinical Trial
Afferent Pharmaceuticals, a biotechnology company dedicated to therapies for neurogenic disorders, recently announced the beginning of a Phase 2 clinical trial to assess its candidate product AF-219 for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
Neurogenic disorders are conditions associated with the central nervous system and affect millions of individuals. They occur when certain nerves become hyper-sensitized due to distress, infection, inflammation or tissue injury; this sensitization can lead to chronic and debilitating symptoms.
AF-219 is an oral drug that can selectively block P2X3 receptors known to be linked to pain and to the sensitization of certain nerve fibers, especially on the joints, skin, and in hollow organs like the lungs and bladder. Nerve sensitization through P2X3 receptors has been linked to inflammatory, visceral and neuropathic pain states, cancer pain, and to migraines, as well as airway hyper-reactivity.
The Afferent Phase 2 clinical trial is a randomized, placebo-controlled, double-blind study to assess the impact of AF-219 treatment (50 mg twice daily) compared to placebo on cough frequency (measured by a cough recording device) and breathlessness. An estimated 30 patients will receive either AF-219 or the placebo for two weeks, and then switch treatments for an additional two weeks.
“Current IPF treatments do not specifically address the cough and breathlessness that are hallmark debilitating symptoms of this disease,” explained Kathleen Sereda Glaub, chief executive officer of Afferent Pharmaceuticals, in a press release. “Given the positive top-line Phase 2 data we recently announced with AF-219 in chronic cough patients showing a statistically significant reduction in cough frequency, we believe our non-narcotic compound may also be beneficial for IPF patients who have a similar, non-productive cough, but no effective treatment options.”
IPF is a chronic, irreversible condition characterized by scarring of the lung tissue. It is estimated that around 70 to 85% of the IPF patients experience cough; in fact, an IPF diagnosis is often based on the presence of a persistent cough. IPF treatments currently available have not been proven to significantly improve chronic cough or breathlessness.
Patients will be enrolled at more than 15 sites in the United States, including centers specialized in pulmonary fibrosis treatment. For more information on the trial (NCT02502097) and on possible enrollment, please visit this link.