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Ovid Therapeutics to Present at the American Academy of Neurology 71st Annual Meeting
NEW YORK, April 18, 2019 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID) continues to build on its neuroscience research platform with the presentation of data from the OV101 (gaboxadol) investigational program for rare neurodevelopmental conditions. Ovid’s presentations on Angelman syndrome and Fragile X syndrome are part of the program at the 71st annual meeting of the American Academy of Neurology (AAN) in Philadelphia (May 4 - 10). The platform presentation and posters will highlight the data from OV101 in adolescents and adults with Angelman syndrome (STARS study) as well as frameworks to assess outcomes in Fragile X syndrome as a precursor to data that Ovid expects to announce in 2H 2019 (ROCKET study). “Ovid’s research efforts are focused on finding treatments for rare diseases, which are defined in the US as conditions affecting fewer than 200,000 people, and specifically, we seek to improve the lives of the approximately 8 million people in the US alone living with neurologic manifestations of rare diseases1,” said Amit Rakhit, MD, MBA, Chief Medical Officer and Head of Research & Development at Ovid. “The data we are presenting at AAN reflect the dedication of our R&D teams to investigate the use of OV101 as a potential treatment for Angelman syndrome and Fragile X syndrome, with each condition having high unmet medical need and no approved therapies.” Ovid Therapeutics continues to expect the initiation of NEPTUNE, a global Phase 3 study of OV101 in children with Angelman syndrome in 2H 2019. Details of the presentations are listed below. Title: Methodology for Development of Indication-Specific Outcome Measures in Rare Disease Trials: An Innovative Research Approach Title: Development of a Conceptual Model to Inform a Clinical Outcome Assessment Strategy in Adolescents and Young Adults with Fragile X Syndrome Title: STARS: Results from a Safety and Efficacy Study of OV101 (gaboxadol) in Adults and Adolescents with Angelman Syndrome About Ovid Therapeutics About OV101 Ovid is developing OV101 for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and thereby address the core symptoms of these disorders. In both these syndromes the underlying pathophysiology includes disruption of the tonic inhibition modulated through the d-subunit of GABAA receptors. In preclinical studies, it was observed that OV101 improved symptoms of Angelman syndrome and Fragile X syndrome. This compound has also previously been tested in over 4,000 patients (over 1,000 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles. In 2018 Ovid announced the successful completion of its Phase 2 (STARS) trials of OV101 in adults and adolescents with Angelman syndrome. In 2H 2019, Ovid expects to initiate a pivotal Phase 3 (NEPTUNE) clinical trial in children aged 4-12 years old. In addition, Ovid is conducting a Phase 2 clinical trial (ROCKET) in Fragile X with results expected in 2H 2019. The FDA has granted Orphan Drug and Fast Track designations for OV101 for both the treatment of Angelman syndrome and Fragile X syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101. The issued patents expire in 2035 without regulatory extensions. About Angelman Syndrome There are no FDA-approved therapies for Angelman syndrome, and treatment primarily consists of behavioral interventions and pharmacologic management of symptoms. Angelman syndrome is associated with a reduction in tonic inhibition, a function of the delta (d)-selective GABAA receptor that allows a human brain to decipher excitatory and inhibitory neurological signals correctly without being overloaded. If tonic inhibition is reduced, the brain becomes inundated with signals and loses the ability to separate background noise from critical information. About Fragile X Syndrome There are no FDA-approved therapies for Fragile X syndrome, and treatment primarily consists of behavioral interventions and pharmacologic management of symptoms. In studies of individuals with Fragile X syndrome and in experimental models, extrasynaptic GABA levels are abnormally reduced, and there is also dysregulation of GABA receptors. We believe this ultimately contributes to a decrease in tonic inhibition, causing the brain to become inundated with signals and lose the ability to separate background noise from critical information. Like the pathophysiology seen in Angelman syndrome, that of Fragile X is associated with a reduction in tonic inhibition, a function of the delta (d)-selective GABAA receptor that allows a human brain to decipher excitatory and inhibitory neurological signals correctly without being overloaded. 1 Source: National Institute of Neurological Disorders and Stroke (NINDS) website. For more information on Ovid, please visit http://www.ovidrx.com/. Forward-Looking Statements Contacts Investors: Alex Gray Media: |