SEATTLE, Jan. 16, 2020 /PRNewswire/ -- Impel NeuroPharma, a late-stage biopharmaceutical company focused on the development and commercialization of transformative therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs, today announced the appointment of Sheena K. Aurora, MD, as Vice President of Medical Affairs – Migraine Franchise. Dr. Aurora will report to Dr. Stephen Shrewsbury, Chief Medical Officer, and will be responsible for leading medical affairs strategy and execution for INP104, Impel's lead product candidate for the treatment of acute migraine.
"I am delighted that Sheena has chosen to join Impel at this exciting time for INP104. She brings nearly 25 years of acclaimed experience in primary headache disorders, both as a respected clinician and a cutting-edge researcher. Having worked with her previously on the MAP Pharmaceuticals program developing MAP0004, a dihydroergotamine (DHE) product, I know she will be an invaluable addition to the Impel team," said Dr. Shrewsbury. "As an organization, we are incredibly pleased that our technology and pipeline piqued the interest of someone of her caliber and we look forward to her contribution as we prepare to submit the New Drug Application (NDA) for INP104 later this year."
Prior to joining Impel, Dr. Aurora was a Senior Medical Fellow, Global Launch Leader at Eli Lilly where she supported the market introduction and medical communications of the company's calcitonin gene-related peptide (CGRP) development platform. Prior to her position at Eli Lilly she was a Clinical Associate Professor, Neurology at Stanford University's School of Medicine. Dr. Aurora's focus is on novel treatments for migraine and other primary headache disorders. A national leader in headache research and treatment, she was the lead author and a key investigator for the phase two study and the pivotal, FREEDOM-301 study, for MAP Pharmaceutical's pulmonary inhaled DHE program (MAP0004), which failed to launch due to lack of regulatory approval. A graduate of Christian Medical College, Dr. Aurora attended Henry Ford Hospital where she studied neurology. She then served as Director of the Headache Clinic at Henry Ford Hospital for four years before becoming Co-Director of the Headache Center at the Swedish Neuroscience Institute in Seattle, Washington. From 2001-2012, Dr. Aurora served as an Assistant Professor in the Department of Neurology at the University of Washington in Seattle. Dr. Aurora was voted as one of the best doctors in Seattle Magazine's "Seattle Best Doctors" in 2010 and 2011.
"My personal connection to migraine led me to devote my career to better understanding the pathophysiology of primary headache disorders and to empathize with the magnitude of impact they can have on those living with these debilitating diseases," said Dr. Aurora. "Despite recent breakthroughs, there continues to be significant unmet need across the spectrum of migraine and other disabling headache disorders, particularly in acute treatment. I believe that INP104 has the potential to transform the way we manage acute migraine and I am excited to lend my experience as Impel ushers this promising program forward."
Dr. Aurora currently serves in five professional societies, including the National Institutes of Health Headache Research Planning, the American Academy of Neurology, Migraine Research Foundation Medical Advisory Board, the National Institute of Neurological Disorders and Stroke Common Data Elements, and the American Headache Society.
INP104 is a drug-device combination product being studied for the treatment of acute migraine. It is comprised of a nasal formulation of dihydroergotamine (DHE) and Impel's proprietary Precision Olfactory Delivery, or POD®, device which delivers drug to the richly vascularized, brain-adjacent upper nasal cavity. The family of POD devices is designed to deliver consistent and predictable doses of drug, offering the potential for rapid and reliable bioavailability without injection. Because INP104 is designed to deliver a reduced dose of DHE compared to FDA-approved and other investigational DHE products in development, patients may be able to reap the established efficacy benefits of DHE, without the undesired side effects that are typically experienced with delivery to the lower nasal space. DHE is an established and highly effective treatment option for acute migraine treatment.
The safety of INP104 is currently being investigated in the "STOP-301 Trial" (Safety and Tolerability of POD-DHE), a Phase 3, open-label safety and tolerability trial evaluating long-term (24/52 week), intermittent use of INP104 for the treatment of acute migraine.
About Acute Migraine
Migraine is a common and debilitating neurological disease characterized by recurrent episodes of severe head pain and associated with nausea, vomiting, sensitivity to light and to sound. Migraine affects approximately 39 million people in the United States. Of the approximately 19 million diagnosed migraine patients, only four million are on prescription treatment. While triptans account for almost 70 percent of migraine therapies, approximately 30 to 40 percent of patients do not respond adequately to triptans and up to 79 percent of the patients who do respond to triptans report being dissatisfied with their current treatment and willing to try a new therapy.
About Impel NeuroPharma
Impel NeuroPharma, Inc., is a privately-held, Seattle-based biopharmaceutical company focused on developing transformative therapies for people living with central nervous system (CNS) disorders that unlock the full potential of therapeutic molecules for patients with high unmet medical needs. Impel NeuroPharma is currently investigating INP104 (POD-DHE) for acute migraine headache, INP107 (POD-carbidopa/levodopa) for reversal of OFF episodes in Parkinson's disease and INP105 (POD-olanzapine) for acute agitation in schizophrenia and bipolar I disorder.
Impel's product candidates are delivered via its proprietary Precision Olfactory Delivery, or POD®, technology which targets the richly vascularized upper nasal cavity with the goal of achieving enhanced bioavailability of therapeutic molecules.
IMPEL, POD and the IMPEL Logo are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at http://impelnp.com.
About Precision Olfactory Delivery or POD® Devices
Impel NeuroPharma's proprietary POD® nasal drug delivery device is designed to deliver drugs to the richly vascularized upper nasal cavity to improve biodistribution and bioavailability of both small molecules and biologic drugs. By consistently and predictably delivering therapeutics to the upper nasal cavity, the POD device may improve overall bioavailability of drugs without IV injection. Impel has developed dry powder and liquid compatible POD devices to improve upon current treatment options for central nervous system (CNS) disorders.
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