NEW YORK, Nov. 23, 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 abstracts from the TAK-935/OV935 (soticlestat) clinical development program in Dravet syndrome or Lennox-Gastaut syndrome (Phase 2 ELEKTRA study) and the OV101 (gaboxadol) clinical development program in Angelman syndrome (Phase 2 STARS study), will be presented at the American Epilepsy Society (AES) 2020 Virtual Congress, taking place December 4-8, 2020.
“There remains significant unmet medical needs for the treatment of Dravet, Lennox-Gastaut, and Angelman syndromes, all of which are neurological conditions with highly impactful effects on individuals, caregivers, and their families,” said Amit Rakhit, MD, MBA, President and Chief Medical Officer at Ovid. “It is important that we continue to analyze data from studies like ELEKTRA and STARS, as we advance understanding of these conditions and work towards our goal of addressing demonstrated gaps in treatment.”
Details of the presentations are as follows:
Title: Efficacy, safety, and tolerability of soticlestat (TAK-935/OV935) as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA); Hahn, et al.
Poster Number: #851
Title: Quantitative analysis of EEG signals in STARS, a Phase 2 safety, tolerability, and exploratory efficacy study of gaboxadol in adolescents and adults with Angelman syndrome; Wang, et al.
Poster Number: #49
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 in development. 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 (DEEs). For more information on Ovid, please visit www.ovidrx.com.
About OV935 (soticlestat)
Soticlestat is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it converts cholesterol into 24S-hydroxycholesterol (24HC) to adjust the homeostatic balance of brain cholesterol. 24HC is a positive allosteric modulator of the NMDA receptor and modulates glutamatergic signaling associated with epilepsy. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity. Recent literature indicates that CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel and that increased expression of CH24H can disrupt the reuptake of glutamate by astrocytes, resulting in epileptogenesis and neurotoxicity. Inhibition of CH24H by soticlestat reduces the neuronal levels of 24HC and may improve excitatory/inhibitory balance of NMDA channel activity.
Ovid and Takeda recently announced positive topline results from the randomized Phase 2 ELEKTRA study of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).
Takeda and Ovid are sharing in the development and commercialization costs of soticlestat on a 50/50 basis, and if successful, the companies will share in the profits on a 50/50 basis. Takeda will be responsible for commercialization in Japan and has the option to be responsible for commercialization in other countries in Asia and other selected countries. Ovid will be responsible for clinical development activities and commercialization of soticlestat in the United States, Europe, Canada and Israel. Under the terms of the agreement, Takeda received equity in Ovid and may be eligible to receive certain milestone payments based on the advancement of soticlestat.
About OV101 (gaboxadol)
OV101 (gaboxadol) is a delta (δ)-selective GABAA receptor agonist in clinical development for the potential treatment of two rare neurodevelopmental conditions: Angelman syndrome and Fragile X syndrome. These receptors are thought to have a central role in tonic inhibition, a key physiological process of the brain believed to be a core pathophysiology underlying certain neurodevelopmental disorders. We believe OV101 is the first and only investigational drug to specifically target the disruption of tonic inhibition, which is believed to be a central cause of many clinical deficits in these disorders. OV101 has demonstrated in laboratory studies and animal models to selectively activate the δ-subunit of GABAA receptors and thereby modulate tonic inhibition. Positive data from the Phase 2 STARS trial of OV101 in adults and adolescents with Angelman syndrome was reported in 2018. Results of a successful Phase 2 signal-finding trial of OV101 in individuals with Fragile X syndrome (ROCKET) were reported in 2020. The Company anticipates initial data from an ongoing pivotal Phase 3 trial in Angelman syndrome (NEPTUNE) in Q4 2020. OV101 has received Rare Pediatric Disease Designation from the FDA for the treatment of Angelman syndrome and was granted Orphan Drug and Fast Track designations for Angelman syndrome and Fragile X syndrome. The European Commission (EC) has granted Orphan Drug designation to OV101 for the treatment of Angelman syndrome. The Company has licensed to Angelini Pharma the right to develop, manufacture and commercialize OV101 for the treatment of Angelman syndrome in the European Union and other countries in the European Economic Area, and also in Switzerland, Turkey, the United Kingdom and Russia.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding: clinical and regulatory development of our programs, potential benefits of OV101, OV935 and our other research programs and the anticipated reporting schedule of clinical data and the potential benefits. 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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