Ovid Therapeutics to Present Data on Its Epilepsy Programs at American Epilepsy Society Annual Meeting (2022)

2022-12-02

临床3期临床结果

Preclinical data demonstrate potential efficacy and safety of OV329 at low, chronic dosing, suggesting an improved pro to other GABA-aminotransferase inhibitors Data from the NIH/NINDs Epilepsy Therapy Screening Program demonstrate that OV329 confers protection from seizure activity in several treatment-resistant animal models New preclinical data on OV350 underscore the potential of activating the KCC2 to alleviate refractory status epilepticus and limit neuronal damage NEW YORK, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company developing medicines designed to conquer epilepsies and meaningfully improve the lives of people affected by brain disorders, today announced that preclinical data supporting its OV329 and OV350 programs in epilepsy and treatment-resistant seizures will be presented at the 2022 American Epilepsy Society (AES) Annual Meeting, taking place December 2-6 in Nashville, Tennessee. “We are excited to return to AES with encouraging preclinical data supporting the anti-seizure potential of what we anticipate will be a first-in-class KCC2 program and best-in-class program for GABA-aminotransferase inhibitors. If successful, these programs will provide hope for people with treatment-resistant epilepsies,” said Jeremy Levin, D. Phil, MB BChir and Chairman and Chief Executive Officer of Ovid Therapeutics. “Our pipeline of potential medicines is designed with unique mechanisms of action to address the diverse, underlying pathophysiology of seizures. Our data suggest OV329 to be a potent, next-generation GABA-AT inhibitor with the potential for seizure reduction with chronic, low dosing. Data presented on OV350 support the therapeutic opportunity associated with activating KCC2, a novel target in epilepsy.” Posters to be presented on Ovid development programs are listed here: Title: Evaluation of OV329, a next-generation GABA-AT inhibitor in a series of pharmaco-resistant seizure models through the NINDS Epilepsy Therapy Screening Program Session Date & Time: 12-2 p.m. CST, Sunday, December 4 Presenter: Patrick Sarmiere, Ph.D. Poster Number: #2.215 Summary: Using the NIH/NINDS Epilepsy Therapy Screening Program (ETSP), a series of signal-finding studies using multiple mouse seizure models, found that OV329 demonstrated efficacy in the subacute models of epilepsy, including corneal kindling model (CKM) and mesial temporal lobe epilepsy (MTLE) model, though it did not mitigate seizures in the 6 Hz psychomotor seizures and maximal electroshock seizures (MES) at the doses tested. In the CKM and MTLE models, a single, high dose of OV329 produced near-complete protection from seizure activity. This pattern is analogous to the effects of vigabatrin and supports additional studies to evaluate repeat dosing at lower dose levels in CKM models. Title: OV329, a next-generation GABA-AT inhibitor, suppresses hippocampal paroxysmal discharges following repeat dosing in a mouse model of mesial temporal lobe epilepsy Session Date & Time: 12-2 p.m. CST, Sunday, December 4 Presenter: Jay Mukherjee, Ph.D. Poster Number: #2.213 Summary: In the MTLE model, a once daily 3.0 mg/kg dose of OV329 administered for eight days significantly reduced the number of seizures by Day 4, with maximum reduction at Day 8, compared to baseline. Furthermore, changes in baseline seizures persisted for seven days following the last administration. Findings demonstrate repeat administration of 3.0 mg/kg is at least as efficacious as a single 10 mg/kg dose of OV329. Title: Direct activation of KCC2 with OV350 arrests refractory status epilepticus and limits the subsequent neuronal injury Session Date & Time: 12-1:45 p.m. CST, Monday, December 5 Presenter: Shu Fun Josephine Ng, Ph.D. Poster Number: #3.278 Summary: OV350 binds with high affinity to KCC2, potassium chloride cotransporter isoform 2, and increases its activity, reducing neuronal Cl- accumulation and limiting the development of hyperexcitability. Additionally, OV350 restored the efficacy of benzodiazepines to treat refractory epilepsies and limit associated brain injuries. In addition, posters characterizing the mechanism of action of soticlestat and other supportive studies are anticipated to be presented by Takeda Pharmaceuticals. Ovid out-licensed soticlestat to Takeda, which is currently evaluating soticlestat in two pivotal, Phase 3 trials for Dravet and Lennox-Gastaut syndromes. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science. Ovid’s pipeline of small molecule and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies. Ovid is developing OV329, a GABA-aminotransferase inhibitor, for treatment-resistant seizures, and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies. In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes. For more information about these and other Ovid research programs, please visit Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation: statements regarding the potential development and use of OV329; the likelihood that data for OV329 will support future development and therapeutic potential; the potential use and development of OV350 and other KCC2 compounds in the Company's library; the suitability of the Company’s library of novel, direct KCC2 transporter activators for a range of formulations and administrations and the timing and status of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Lennox-Gastaut and Dravet syndromes. You can identify forward-looking statements because they contain words such as "anticipates," "believes," "expected," "intends," "plan," "potentially," and "will," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). 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, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, the risk that Ovid may not be able to realize the intended benefits of its technology and risks to Ovid’s or any of its partners’ abilities to meet anticipated deadlines and milestones presented by the ongoing COVID-19 pandemic. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2022, and in future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts Investors and Media: Ovid Therapeutics Inc. Meg Alexander 917-943-6681 malexander@ovidrx.com OR Investors: Argot Partners Maeve Conneighton 212-596-7231 ovid@argotpartners.com