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OV329 demonstrated robust anti-seizure activity in multiple preclinical seizure and epilepsy models, including treatment-resistant seizures
Data demonstrate OV329 has the potential for an improved ocular safety profile and therapeutic index compared to other GABA-aminotransferase (GABA-AT) inhibitors
Ovid expects to submit an Investigational New Drug (IND) application in 2H 2022
NEW YORK, June 06, 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, presented data at the 2022 Epilepsy Foundation Pipeline Conference. New preclinical data support the robust anti-seizure activity of OV329, a next-generation GABA-aminotransferase (GABA-AT) inhibitor in development for rare adult and pediatric epilepsies.
“Inhibiting the GABA-AT enzyme has proven to be a highly effective mechanism of action for reducing seizures; yet, safety challenges associated with the currently available medicine in the class significantly limit its use,” said Claude Nicaise, M.D., Head of Research & Development at Ovid. “OV329 is a potential best-in-class GABA-AT inhibitor that could offer patients and families robust seizure reduction without the ocular side effects seen in similar medicines. We plan to advance an IND submission for OV329 to the FDA and expect to initiate clinical studies later this year.”
HIGHLIGHTS OF PRECLINICAL FINDINGS
Robust anti-seizure activity: Findings from preclinical seizure and epilepsy models indicate that OV329 significantly reduced focal and generalized seizures, including pharmacoresistant seizure phenotypes.
Therapeutic dose with enhanced safety margin: A preclinical model of focal seizures (Mesial Temporal Lobe Epilepsies model) in mice demonstrated that repeated administration of OV329 at a dose of 3 mg/kg reduced seizures by approximately 70% by the eighth day of treatment, as compared to placebo. Data presented by Ovid last month at the 2022 EILAT XVI Conference on New Antiepileptic Drugs and Devices found the same dose (3 mg/kg) in rats was well-tolerated with no ocular changes observed following 45 days of repeated exposure, as compared to a generally equivalent human therapeutic dose of vigabatrin (300 mg/kg) which did show ocular toxicity changes at 45 days.
Potential seizure protection: A mouse model of generalized seizures (Corneal Kindled model) showed a single dose of OV329 led to significant seizure reduction over a prolonged period. Another model using doses of OV329 at 40 mg/kg suggests that it may prevent the occurrence of seizures, and therefore, may have potential for antiepileptogenesis.
“OV329 was designed to be a more potent GABA-AT inhibitor than vigabatrin, the only other approved medicine in the class,” said Julia Tsai, Ph.D., Head of Clinical Development and Medical Affairs at Ovid Therapeutics. “We are excited to potentially move it into human trials and further characterize its therapeutic promise for patients.”
OV329 SAFETY FINDINGS
In preclinical animal safety studies, OV329 was well-tolerated with no reported genotoxicity, cardiovascular or central nervous system effects at expected therapeutic doses. Importantly, in a translatable animal model, OV329 showed no adverse ocular effects at an anticipated therapeutic dose of 3 mg/kg after 45 days of dosing. In comparison, ocular effects have been seen in about half of the animals treated with vigabatrin at a generally equivalent human therapeutic dose of 300 mg/kg.
OV329 is a potent, next-generation GABA aminotransferase inhibitor being developed for the potential treatment of rare and treatment-resistant forms of epilepsy and seizures, such as seizures associated with tuberous sclerosis complex, infantile spasms, and focal seizures. Low levels of GABA, the primary inhibitory neurotransmitter in the brain, have been linked to neuronal hyperexcitability. OV329 is believed to work by reducing the activity of GABA-AT, thereby increasing levels of GABA in the brain, and potentially suppressing neuronal hyperexcitability known to cause seizures. By engaging a well-characterized target with a similar mechanism of action to vigabatrin, OV329 may be a potential best-in-class GABA-AT inhibitor that offers enhanced efficacy and an improved safety profile.
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 www.ovidrx.com.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the reporting of preclinical data for OV329, the potential use of OV329 to treat rare and treatment-resistant forms of epilepsy and seizures, the timing for filing of an IND for OV329, the clinical and regulatory development of OV329, including the anticipated timing of clinical trials of OV329, the likelihood that data for OV329 will support future development and therapeutic potential, and the potential development of OV350. You can identify forward-looking statements because they contain words such as “will,” “believes,” “intends,” “anticipates” 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, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its technology or its business strategy, risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions 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 Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 10, 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.
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