Afferent Pharmaceuticals has announced the results of a Phase 2 clinical trial that showed the company’s drug candidate AF-219 reduced daytime cough frequency by 75%.
According to a Burns McClellan news release, the results of the trial support Afferent’s current development strategy to initiate a Phase 2b clinical trial early in 2015. AF-219 is a selective, non-narcotic agent that is orally administered and targets the mechanism by which certain nerve fibers become hyper-sensitized and lead to chronic symptoms, such as cough.
Jacky Smith, MB, ChB, MRCP, Phd, lead author of the article, says, “Patients with refractory cough suffer from debilitating coughing and need new treatment options. Current therapies are largely ineffective, or can have significant side effects or potential for abuse, since most contain opioids or opiate-derivatives.” Smith adds, “This is the first published study showing clear clinical benefit of a treatment for refractory cough. I am excited by these clinical results and believe that AF-219 represents a promising new antitussive.”
In the 24-patient randomized clinical trial, the data revealed a 75% reduction in daytime cough frequency compared to placebo in the intent-to-treat population and 84% reduction in cough frequency in the per protocol analysis. In addition, the results showed significant improvements over placebo in secondary endpoints and patients enrolled in the study were coughing approximately 40 times per hour and for over 10 years on average. Any adverse events were either mild or moderate in severity.
Kathleen Sereda Glaub, CEO of Afferent, states, “The remarkable findings in cough, as published in The Lancet, provide the first evidence that AF-219 may be able to reduce chronic coughing in patients whose nerve fibers have been hyper-sensitized. As a selective, oral and non-narcotic agent, we hope that AF-219 will enhance patients’ treatment options.”
She explains, “With approximately two-thirds of responders to AF-219 treatment showing more than a 50% reduction in cough frequency, we plan to advance the development of AF-219 by initiating a Phase 2b study in patients with chronic cough early next year and to initiate other studies in preparation for registration studies.”
Source: Burns McClellan