Vivera Executes Letter of Intent to Enter a Cooperative Research and Development Agreement with the NINDS of NIH to Assess Therapeutic Agents for Potential Treatments of Stuttering Disorders
NEWPORT BEACH, Calif.—Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), an Institute within the National Institutes of Health (NIH) that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide.
Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS.
The initiative is unique because of the individuals it will be led by: Vivera Biosciences’ Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS’ Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for.
“I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community,” said Dr. Maguire.
Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering.
“This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter,” said Dr. SheikhBahaei.
Dr. SheikhBahaei’s graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering.
“Vivera is confident in our choice in partnership with NIH,” said Vivera’s Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A.
“Since day one, Vivera has been dedicated to the research and development of patient-centric treatments,” said Paul Edalat, CEO of Vivera. “This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company’s commitment to our mission.”
About Vivera Pharmaceuticals
Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.