SAN MATEO, Calif.--(BUSINESS WIRE)--Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, today announced that it has initiated a Phase 2 clinical trial with AF-219 in idiopathic pulmonary fibrosis patients (IPF) with cough. AF-219 is a selective, non-narcotic and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms. The study is expected to enroll at least 30 patients at more than 15 sites in the United States, including leading pulmonary fibrosis specialty treatment centers.
The randomized, double-blind, placebo-controlled, crossover study will measure the effect of AF-219 compared to placebo at a dose of 50 mg twice daily for two weeks on cough frequency, as measured objectively by a cough recording device. Following a two-week washout period, patients are then crossed over to the alternate treatment arm and dosed twice daily for an additional two weeks. Cough frequency is measured at each baseline and at the end of each treatment period. The study will also examine the effect of AF-219 on breathlessness, another debilitating symptom from which IPF patients suffer.
“Current IPF treatments do not specifically address the cough and breathlessness that are hallmark debilitating symptoms of this disease,” said Kathleen Sereda Glaub, chief executive officer of Afferent Pharmaceuticals. “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.”
Idiopathic pulmonary fibrosis is a chronic, irreversible lung disease characterized by scarring of lung tissue, with no known cause. Primary symptoms are cough and shortness of breath. The National Institutes of Health (NIH) has recently reported the prevalence of IPF in the U.S. is 200,000 patients, making it an orphan indication. Approximately 70-85% of IPF patients suffer from cough. IPF patients are often first diagnosed as a result of their persistent cough. Currently available drug treatments have not been shown to affect IPF patients’ chronic cough or breathlessness, symptoms that significantly impair quality of life and progress as the disease worsens.
For more information on the Phase 2 IPF cough trial, please visit clinicaltrials.gov
In addition to the Phase 2 IPF cough trial, Afferent is currently conducting a Phase 2b lower-dose escalation study with AF-219 in chronic cough patients. Top-line data from this study are expected in the first quarter of 2016. Additionally, a 12-week Phase 2b trial with AF-219 in chronic cough in the U.S. and United Kingdom is planned.
About AF-219 and P2X3 Receptor-Mediated Sensitization
AF-219 is an orally available, first-in-class compound that selectively blocks P2X3, a purinergic receptor which plays a key role in the sensitization of certain nerves, or C-fiber afferents, that are primarily found in the skin, joints and hollow organs, such as the lungs and bladder. These nerves become activated and sensitized under pathological conditions mediated by a common cellular signal, ATP, following nerve injury, infection or inflammation. Afferent’s compounds selectively target P2X3 channels in order to block the activation of these afferents by ATP. Selective P2X3 inhibition leaves important normal defensive sensing processes that are controlled by other, distinct nerves, intact.
P2X3 receptor-mediated sensitization has been implicated in inflammatory, visceral and neuropathic pain states, as well as airways hyper-reactivity, migraine, itch and cancer pain.
About Afferent Pharmaceuticals
Afferent Pharmaceuticals is a clinical-stage biotechnology company and leader in the development of novel drugs for the treatment of a range of neurogenic disorders. These disorders affect millions of patients who suffer from chronic respiratory and urologic sensory pathologies as well as chronic pain and cardiovascular disorders, and who have limited, if any, treatment options. These chronic pathologies arise when certain nerves become hyper-sensitized as a result of inflammation, distress, infection or tissue injury, which may remain chronically sensitized for months and even years.
Afferent is developing a portfolio of compounds that selectively block P2X3, which plays a key role in the sensitization of these nerves. Afferent’s lead molecule, AF-219, is in Phase 2 clinical development for the treatment of chronic cough. For more information on the company, please visit Afferent’s website at www.afferentpharma.com.