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A potential next-generation GABA-aminotransferase inhibitor for rare epilepsy with limited treatment options
NEW YORK, Jan. 05, 2023 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID) announces a medicinal product designed to overcome epilepsy and meaningfully improve the lives of people affected by brain disorders administered OV329 to healthy volunteers at a biopharmaceutical company developing In late December 2022 as part of a Phase 1 trial. We are conducting studies to evaluate the safety and target engagement associated with single and multiple doses of OV329.
“Inhibition of the GABA-aminotransferase (GABA-AT) enzyme is an effective mechanism for reducing seizures. Favorable dosages in comparison. We thank the epilepsy community and the individuals participating in this Phase 1 trial. The results will inform our development plans and hopefully prompt treatment. We will proceed with trials with people experiencing bouts of resistance.”
The Phase 1 study of OV329 is a randomized, double-blind, placebo-controlled human trial being conducted at Duke University School of Medicine. The study consists of two parts, starting with a single escalating dose part followed by a multiple escalating dose part. Both parts are cohort gates. This study in healthy volunteers will investigate several endpoints including safety, tolerability, pharmacokinetics, and target engagement levels as measured by magnetic resonance spectroscopy (MRS). GABA-AT target engagement levels may be a potential indicator of the potential therapeutic effect of OV329. This is because specific increases in GABA have previously been correlated with decreased seizures.1,2,3 Ovid plans to enroll more than 60 people in the trial and expects final results in the first half of 2024.
Amy E. Brin, CEO of the Child Neurology Foundation, said: “Families with rare forms of epilepsy, such as infantile spasms and tuberous sclerosis-related seizures, will benefit from more treatment options. We look forward to the results of these studies.” I have.”
Contact us for more information about the OV329 Healthy Volunteer Study. [email protected]
OV329 is a next-generation GABA-aminotransferase (GABA-AT) inhibitor to treat rare and treatment-resistant epilepsy and seizures, including conditions with tuberous sclerosis complex-associated seizures, infantile cramps, and focal onset. is being developed for the potential treatment of Seizure. Low levels of GABA, a major inhibitory neurotransmitter in the brain, are associated with neuronal hyperexcitability. OV329 works by decreasing the activity of GABA-AT, thereby increasing GABA levels in the brain and potentially suppressing neuronal hyperexcitability, which is known to cause seizures. It is considered OV329 has the potential to be a best-in-class GABA-AT inhibitor that offers enhanced efficacy, improved safety profile and more optimal dosing.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company committed to defeating seizures and brain damage with courageous science. Ovid’s pipeline of small molecule and gene therapy candidates aims to meaningfully improve the lives of people and families suffering from epilepsy. 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 epilepsy. In addition, Ovid maintains significant financial interest in the future regulatory development and commercial potential of soticlestat, which Takeda is responsible for promoting globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor currently in Phase 3 trials for Dravet syndrome and Lennox-Gastaut syndrome. For more information on these and other of his Ovid research programs, please visit www.ovidrx.com.
This press release contains certain disclosures, including “forward-looking statements.” The potential timing of a Phase 1 trial of OV329 and the potential for OV329 data to support future development and therapeutic potential. The use and development potential of OV350 and the status of Takeda’s two pivotal phase III trials evaluating soticlestat for Lennox-Gastaut syndrome and Dravet syndrome. Forward-looking statements may contain words such as “expect,” “believe,” “anticipate,” “intend,” “plan,” “potentially,” “will,” and similar statements. (and other words or expressions referring to future events, circumstances, or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Forward-looking statements are forward-looking and are subject to inherent uncertainties, risks and changes in circumstances. These forward-looking statements are neither statements of historical fact nor guarantees of future performance. Important factors that could cause actual results to differ materially from the forward-looking statements include the uncertainties inherent in preclinical and clinical development and regulatory approval processes; including, but not limited to, risks that may not be realized. that technology. Additional risks that could cause actual results to differ materially from the forward-looking statements are in his Ovid’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 8. under the caption “Risk Factors”. , 2022 and future Ovid filings with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release and Ovid may not make any statements, whether as a result of new information, future events, changes in circumstances or otherwise. We do not undertake any obligation to update any forward-looking statements contained herein. otherwise as required by law.
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1Petrov OA, Rothman DL, Behar KL, Collins TL, Mattson RH. Her GABA levels in the human brain rise rapidly after initiation of vigabatrin therapy. Neurology. 1996 Dec;47(6):1567-71. Doi: 10.1212/wnl.47.6.1567. PMID: 8960747.
2 Petrov OA, Rothman DL, Behar KL, Mattson RH. Her GABA levels in the human brain are elevated after initiation of vigabatrin therapy, but not further with increasing doses. Neurology. 1996 May;46(5):1459-63. Doi: 10.1212/wnl.46.5.1459. PMID: 8628502.
3Prescott AP, Miller SR, Ingenito G, Hoover RS, Kondo DG, Renshaw PF. In vivo detection of CPP-115 target engagement in the human brain. Neuropsychopharmacology. 2018 Feb;43(3):646-654. Doi: 10.1038/npp.2017.156. Epub 2017 25 Jul. PMID: 28741622; PMCID: PMC5770752.