- Four abstracts from the OV101 (gaboxadol) clinical development program in Angelman Syndrome and Fragile X Syndrome to be presented
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
Poster Number: #587
Title: The Phase 2a ROCKET Trial Investigating Gaboxadol (OV101) in Adolescents and Young Adults with Fragile X Syndrome; Berry-Kravis, et al
Poster Number: #676
Title: The Adaptation and Utility of the Clinical Global Impression Scale for Studying Treatment Outcomes in Neurodevelopmental Conditions; Jaeger, et al
Poster Number: #46
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
Poster Number: #588
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The Company’s most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharmaceutical Company Limited for the potential treatment of rare developmental and epileptic encephalopathies (DEE). For more information on Ovid, please visit www.ovidrx.com.
About OV101 (gaboxadol)
OV101 is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first investigational drug to specifically target the disruption of tonic inhibition, a central physiological process of the brain that is thought to be the underlying cause of certain neurodevelopmental disorders. OV101 has demonstrated in laboratory studies and animal models to selectively activate the δ-subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and thereby impact neuronal activity through modulation of tonic inhibition.
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 δ-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.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the potential benefits, clinical and regulatory development, the likelihood that data will support future development, and the association of data with treatment outcomes. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include uncertainties in the development and regulatory approval processes, and the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the Securities and Exchange Commission under the caption “Risk Factors.” Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid’s business and the global economy. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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