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February 12, 2016 6:37 PM ET

Biotechnology

Company Overview of Afferent Pharmaceuticals, Inc.

Company Overview

Afferent Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, develops small molecule compounds that target P2X3 receptors for the treatment of chronic pain, respiratory, and urological conditions. Its products include AF-219 and AF-130, P2X3 antagonists that is used for patients with osteoarthritis pain, treatment-refractory chronic cough, and interstitial cystitis/bladder pain syndrome; and AF-220, a second-generation P2X3 antagonist. The company was founded in 2009 and is based in San Mateo, California.

2929 Campus Drive

Suite 230

San Mateo, CA 94403

United States

Founded in 2009

Phone:

650-286-1276

Fax:

650-286-1833

Key Executives for Afferent Pharmaceuticals, Inc.

Co-Founder and Chief Scientific Officer
Chief Medical Officer
Age: 65
Chief Technology Officer
Vice President of Clinical Operations
Vice President of Regulatory Affairs and Project Management
Compensation as of Fiscal Year 2015.

Afferent Pharmaceuticals, Inc. Key Developments

Afferent Pharmaceuticals, Inc. Advances Novel Molecule, AF-130, to Phase 1 Clinical Trial

Afferent Pharmaceuticals, Inc. announced initiation of the company’s Phase 1 trial of AF-130, a selective and differentiated P2X3 antagonist. Afferent’s Phase 1, double-blind, randomized, placebo-controlled trial is designed to assess the safety, tolerability and pharmacokinetics of single ascending doses and, in a second cohort, multiple ascending doses of AF-130 administered to healthy subjects. Pending the progress of the Phase 1 trial, Afferent intends to evaluate AF-130 in multiple conditions, including treatment-resistant hypertension, and potentially in heart failure, migraine and visceral pain. The goal of treatment with a P2X3 inhibitor is to restore normal physiological function by blocking ATP activation of P2X3 channels that otherwise leads to sensitization of certain nerves and pathological signs and symptoms. Afferent’s lead product, AF-219, is currently being developed for the treatment of pathologic cough, including chronic cough, and cough in idiopathic pulmonary fibrosis (IPF) patients. Afferent’s clinical candidates – AF-219 and AF-130 – are orally available, first-in-class compounds that selectively block P2X3 receptors. P2X3 receptors play a key role in the sensitization of certain sensory nerves, notably C-fiber afferents. These nerves become activated and sensitized under pathological conditions mediated by a common cellular signal, ATP, when it is released in high concentrations due to cellular distress following injury or infection. Afferent’s compounds selectively block ATP activation of P2X3 channels, reducing a range of sensory signs and symptoms. P2X3 receptor-mediated sensitization has been implicated in inflammatory, visceral and neuropathic pain states, as well as airways hyperreactivity, treatment-resistant hypertension, heart failure, migraine, itch and cancer pain.

Afferent Pharmaceuticals Announces Executive Appointments

Afferent Pharmaceuticals announced the appointments of Prabha N. Ibrahim, Ph.D., as chief technology officer and Michelle Carpenter, J.D., RAC, as vice president of regulatory affairs and project management. Dr. Ibrahim will be responsible for directing manufacturing of drug supplies, from initial scale up to registration and commercial supplies, as well as management of Afferent’s intellectual property portfolio, while Ms. Carpenter will be responsible for global regulatory affairs as well as project management for the company’s development stage programs. Dr. Ibrahim brings more than 23 years of experience in drug discovery and development, having served in a number of senior leadership positions at Plexxikon Inc., most recently as senior vice president of chemistry and non-clinical development. Ms. Carpenter brings 25 years of biopharmaceutical experience in regulatory strategy and operations in support of drug development and commercialization. Prior to joining Afferent, Ms. Carpenter held senior positions at Acucela.

Afferent Pharmaceuticals, Inc. Announces Phase 2 Clinical Trial with AF-219 in Cough in Idiopathic Pulmonary Fibrosis Patients

Afferent Pharmaceuticals announced that it has initiated a Phase 2 clinical trial with AF-219 in idiopathic pulmonary fibrosis patients 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 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. 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 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. 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.

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