Ovid Therapeutics to Present at the Child Neurology Society/International Child Neurology Association (CNS/ICNA) Virtual Congress
NEW YORK, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced that four abstracts from the OV101 (gaboxadol) clinical development program will be presented at the Child Neurology Society/International Child Neurology Association (CNS/ICNA) 2020 Virtual Congress, taking place October 12 – October 23, 2020.
The presentations include additional data and analyses from the Phase 2 ROCKET clinical trial of OV101 in individuals with Fragile X Syndrome; data on seizure and EEG outcomes from the Phase 2 STARS clinical trial in individuals with Angelman Syndrome; encore presentations of a study of caregiver insights in Angelman Syndrome; and the utility of the Clinical Global Impression (CGI) scale for studying outcomes in neurodevelopmental conditions.
“Ovid is passionately committed to the development of OV101 to address the significant unmet medical need in individuals with both Angelman and Fragile X Syndromes – two neurological conditions with tremendous caregiver and family impact with no approved treatment options for either,” said Amit Rakhit, MD, MBA, President and Chief Medical Officer at Ovid. “These data will contribute to evolving scientific exchange and advancing discussion around neurodevelopmental conditions, caregiver concerns, and the urgency to develop new medicines for these conditions.”
Details of the presentations are as follows:
Title: Caregiver Insight on the Core Domains in Angelman Syndrome; Adera, et al
Title: The Phase 2a ROCKET Trial Investigating Gaboxadol (OV101) in Adolescents and Young Adults with Fragile X Syndrome; Berry-Kravis, et al
Title: The Adaptation and Utility of the Clinical Global Impression Scale for Studying Treatment Outcomes in Neurodevelopmental Conditions; Jaeger, et al
Title: STARS, a Phase 2 Safety, Tolerability, and Exploratory Efficacy Study of Gaboxadol in Adolescents and Adults with Angelman Syndrome: Seizure and EEG Outcomes; Wang, et al
About Ovid Therapeutics
About OV101 (gaboxadol)
Ovid is developing OV101 for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and thereby address several core symptoms of these conditions. In both these syndromes, the underlying pathophysiology includes disruption of 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 more than 4,000 patients (more than 1,000 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles. Ovid is conducting a pivotal Phase 3 clinical trial with OV101 in Angelman syndrome (NEPTUNE) and has completed a Phase 2 signal-finding clinical trial with OV101 in Fragile X syndrome (ROCKET).
OV101 has received Rare Pediatric Disease Designation from the FDA for the treatment of Angelman syndrome. The FDA has also granted Orphan Drug and Fast Track designations for OV101 for both the treatment of Angelman syndrome and Fragile X syndrome. In addition, the European Commission (EC) has granted orphan drug designation to OV101 for the treatment of Angelman 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.
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