Center for Cough clinical and research team conduct cough research studies to develop new cough treatment options.

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Major Breakthrough in Cough Treatment on the Horizon

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There’s a major breakthrough in cough treatment on the horizon and it shows promising preliminary results!

Dr. Mandel Sher and Center for Cough are currently enrolling volunteer patients in the clinical trials of AF-219, a new drug that shows promise as a breakthrough in cough treatment. For a limited time, patients have an opportunity to try this promising new drug before it’s available to the general public.  Please call Amy today, Center for Cough’s Clinical Research Nurse Coordinator, to learn more about this promising new cough treatment: (727) 393- 8067.

Do you know someone who has been coughing for months, years, or even decades? Has that person seen his or her doctor and tried different cough treatments or cough remedies only to fail and still be coughing? Does that person describe their cough as trying to cough-up something tickling the back of his or her throat? As a concerned family member or friend, are you thinking that this person will never decrease the intensity of his or her cough or get rid of it completely? Read more

Dr. Sher Leads National Conversation on Chronic Cough

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“Cough is the most frequent illness-related reason people visit their doctor,” according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

But not all coughs are created equal.   Some people are dealing with an active upper respiratory infection or the aftermath, and others have a cough that just won’t go away.  A cough that lasts eight weeks or longer is considered a “chronic cough.” 10% of the population have a chronic cough and a large number from this group cannot find effective treatment because their physicians are diagnosing and treating the symptoms rather than the underlying cause. Read more

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Clinical Trials Conducted at Center for Cough

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Dr. Mandel Sher and Center for Cough are grateful to their many patients who volunteer for clinical trials. The Wall Street Journal reported on April 12, 2016  that fewer than 10% of Americans participate in clinical trials to test new drugs and treatments because they are unaware of that option or their doctors may not suggest them. Trusting their doctor and having a desire to advance medicine and therapies are the motivating factors for patients’ participation. Please learn more about Amy by visiting Center for Cough’s website.  Contact Center for Cough today to learn about opportunities to participate in clinical research:  727-393-8067.

AF-219: Promising New Cough Treatment

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Dr. Mandel Sher and Center for Cough are the nation’s leading site for clinical research trials for new cough treatments.  Currently, Center for Cough is enrolling eligible patients in Afferent Pharmaceuticals AF-219 clinical research trial. Preliminary results suggest AF-219 may be a promising new cough treatment.

Contact Amy, Center for Cough’s Clinical Research Coordinator, to learn more about this clinical research trial and other that may be available:  727-393-8067

“…Pathologic Cough – Debilitating & Potentially Chronic Neurogenic Disorder Affecting Millions Cough is the symptom for which patients most often seek medical attention. Pathologic cough or non-productive cough serves no functional purpose, and can occur following an upper respiratory infection. In most patients, this cough manifests itself as an acute cough lasting a few weeks. However, in some patients, sensitized nerve fibers fail to return to a normal quiescent state, resulting in sub-acute or chronic cough lasting months to years. The prevalence of chronic cough is estimated to be over 10% of adults in the U.S. While an underlying etiology may contribute to cough in some of these patients (such as GERD, asthma, COPD, etc.), many patients are not well-controlled for their cough even with treatment for such underlying etiology, or with the addition of currently available cough medications…” read more

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Positive Results in Chronic Cough Trial

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Afferent Pharmaceuticals Announces Positive Results in Phase 2b Chronic Cough Trial

AF-219 Treatment Significantly Reduces Cough Frequency in Patients

SAN MATEO, Calif.–(BUSINESS WIRE)–Afferent Pharmaceuticals, a leader in the development of small molecule compounds targeting P2X3 for the treatment of poorly managed and common neurogenic disorders, such as chronic cough, today announced positive top-line results from its Phase 2b dose escalation clinical trial of AF-219 in chronic cough patients. 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 results of this clinical trial will be presented at a scientific meeting in the future.

“Our promising Phase 2b results demonstrate AF-219’s potential to be a first-in-class therapy, with the potential to replace the current, often ad hoc treatments that have little impact on cough frequency or result in possibly serious side effects or carry abuse potential,” said Kathleen Sereda Glaub, Afferent’s chief executive officer. “With the robust reductions in cough frequency following AF-219 treatment confirmed in this second study, we are committed to a full development program to advance this non-narcotic treatment for the benefit of the many patients suffering from chronic cough.”

Jaclyn Smith, M.B., Ch.B., MRCP, Ph.D. and professor and honorary consultant in Respiratory Medicine, University of Manchester and University Hospital Manchester NHS Foundation Trust, a leading investigator in the field of chronic cough, said “Chronic cough has widespread effects on patients’ quality of life, and a new therapy with increased efficacy and substantially reduced adverse events will have a meaningful impact and address a significant unmet need. I am excited by the consistency of the findings demonstrated in the AF-219 program, and I look forward to the continuing progress of these efforts.”

Significant Efficacy and Improved Tolerability Shown With Lower Doses

The study randomized 29 chronic cough patients. Doses of 50 mg, 100 mg, 150 mg and 200 mg twice daily for 4 days demonstrated significant reduction in cough frequency, including at the lowest dose of 50 mg twice daily. Cough frequency was measured objectively utilizing a cough recording device, with periodic measurements following AF-219 treatment compared to a baseline recording.

All AF-219 doses, including the lowest dose of 50 mg twice daily, demonstrated a statistically significant reduction in awake cough frequency compared to placebo (p≤0.002).

AF-219 was generally well tolerated. The incidence of decreased taste acuity, as observed in the first study at 600 mg twice daily, was much less at the 50 mg dose. Only one patient discontinued treatment at any dose in the current study, due to the taste effect.

Afferent’s previous high-dose proof-of-concept trial demonstrated a 75% reduction in cough frequency (Intent-to-Treat population) in 24 refractory chronic cough patients with AF-219 treatment 600 mg twice daily for two weeks. In the first study, six of 24 patients discontinued treatment due to a change in taste acuity (published in the Lancet, March 2015; online November 2014).

About the Phase 2b Trial

The 29-patient randomized, double-blind, placebo controlled, Phase 2b crossover study was conducted at 10 clinical sites in the U.S. Patients were randomized to either AF-219 or placebo arms. Those in the treatment group received AF-219 50 mg, followed by a titration up to 100 mg, 150 mg and 200 mg, with each dose given twice daily for four days. Treatment period one was followed by a 3-5 day washout period. Patients were then crossed over to the alternate arm of the study and treated with either AF-219 or placebo for 16 more days.

Pathologic Cough – Debilitating & Potentially Chronic Neurogenic Disorder Affecting Millions

Cough is the symptom for which patients most often seek medical attention. Pathologic cough or non-productive cough serves no functional purpose, and can occur following an upper respiratory infection. In most patients, this cough manifests itself as an acute cough lasting a few weeks. However, in some patients, sensitized nerve fibers fail to return to a normal quiescent state, resulting in sub-acute or chronic cough lasting months to years. The prevalence of chronic cough is estimated to be over 10% of adults in the U.S. While an underlying etiology may contribute to cough in some of these patients (such as GERD, asthma, COPD, etc.), many patients are not well-controlled for their cough even with treatment for such underlying etiology, or with the addition of currently available cough medications.

P2X3 Receptors Role in Hyper-sensitization and Pathology

The P2X3 receptor, the target for Afferent’s lead AF-219, is predominantly expressed in nociceptive C-fiber primary afferent nerves that innervate most tissues and organs, including the skin, joints, and the hollow organs such as the airways and bladder. These primary afferent neurons are not important in normal physiological or defensive sensing processes, but rather become activated and sensitized under pathological conditions by a common cellular signal, ATP, such as following nerve injury, infection or inflammation.

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.

Afferent’s first-in-class compounds selectively target P2X3 channels in order to block the activation of these afferents by ATP.

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 debilitating 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 nerve fibers become hyper-sensitized as a result of inflammation, distress, infection or tissue injury, and sometimes remain chronically sensitized for months and even years.

Afferent is developing molecules that selectively block P2X3, a purinergic receptor, which plays a key role in the sensitization of these nerves. Afferent’s lead molecule, AF-219, is a first-in-class P2X3 antagonist, and is being developed for the treatment of chronic cough. For more information on the company, please visit Afferent’s website atwww.afferentpharma.com.

Contacts

Afferent Pharmaceuticals Amy Pfeiffer, 650-286-1276 info@afferentpharma.com or Media: Burns McClellan, Inc. Justin Jackson, 212-213-0006, Ext. 327 jjackson@burnsmc.com