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Ovid Therapeutics Inc. (NASDAQ: OVID) is a pioneering biopharmaceutical company dedicated to creating transformative medicines for patients and families affected by rare neurological disorders. The company’s primary focus is on developing treatments for conditions such as Angelman syndrome and Fragile X syndrome through its innovative drug candidates, OV101 and OV935.
OV101, Ovid’s lead drug candidate, is designed to address the symptoms of Angelman syndrome and Fragile X syndrome. The company has initiated the Phase 2 STARS trial to evaluate the efficacy of OV101 in adults with Angelman syndrome and is also conducting a Phase 1 trial in adolescents to identify suitable doses for younger patients. These efforts underscore Ovid’s commitment to advancing treatments for underserved communities.
In collaboration with Takeda Pharmaceutical Company Limited, Ovid is developing OV935 for the treatment of rare epileptic encephalopathies. This partnership aims to leverage both companies' strengths to accelerate the development of novel therapies. Ovid’s pipeline features a range of potential first-in-class and in-class mechanisms of action, highlighting the company's innovative approach to tackling rare epilepsies and seizure-related neurological disorders.
Ovid Therapeutics is also committed to maintaining transparency and fostering a supportive community. The company’s Community Guidelines, available on their website, outline their dedication to integrity and patient-focused values.
Recent corporate updates include the announcement of fourth-quarter and annual 2023 financial results and the first-quarter 2024 financial results, which provide insights into the company’s financial health and strategic direction. Ovid continues to make significant strides in its clinical and research pipeline, aiming to bring meaningful change to the lives of those affected by rare neurological disorders.
Ovid Therapeutics announced the publication of preclinical studies in eNeuro, showcasing OV329's potential effectiveness in treating drug-resistant seizures. OV329, a next-gen GABA-AT inhibitor, demonstrated higher potency compared to vigabatrin, an FDA-approved GABA-AT inhibitor. Sustained exposure to OV329 in mice reduced GABA-AT activity and increased GABA levels in the brain, potentially offering robust and sustained seizure reduction. Additionally, OV329 reduced status epilepticus severity and prevented benzodiazepine resistance development in mice. These findings suggest OV329's differentiated profile and potential for better safety, dosing, and efficacy in refractory seizure treatment.
Ovid Therapeutics and Graviton Bioscience announced positive Phase 1 trial results for their OV888/GV101 capsule, a potential first-in-class therapy for cerebral cavernous malformations (CCM). The trial met its primary objective by demonstrating a favorable safety and tolerability profile, with no serious adverse events reported. Secondary endpoints showed target pharmacokinetic profiles were achieved, supporting once-daily dosing. The capsule was biologically active, producing dose-dependent pharmacodynamic effects. A Phase 2 study is planned for the second half of 2024. The findings indicate OV888/GV101 could be the first oral treatment for CCM, aiming to restore brain endothelial cell function, reduce inflammation, and prevent fibrosis.
Ovid Therapeutics reported on Takeda's Phase 3 study results for soticlestat, a treatment for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). The Skyline study in DS narrowly missed its primary endpoint but showed significant effects in secondary endpoints with p-values ≤ 0.008. The Skyway study in LGS missed its primary endpoint. Soticlestat had a favorable safety profile across both studies. Takeda will discuss the total data with regulatory authorities. Ovid highlighted its differentiated pipeline and financial strategy, with cash runway expected to last into H1 2026. Key upcoming milestones include Phase 2 and Phase 1 trials for OV888, OV329, and the KCC2 direct activator OV350.
Ovid Therapeutics (NASDAQ: OVID) has provided business updates and first-quarter 2024 financial results. Key highlights include the completion of two Phase 3 trials by Takeda for soticlestat, expected to treat Lennox-Gastaut and Dravet syndromes, with topline data anticipated in H1 2024. A Phase 1 trial for OV888 (GV101) has concluded, showing no serious adverse events, with Phase 2 set to begin in H2 2024. Financials reveal cash and equivalents of $90.3 million, enough to support operations into H1 2026. Revenue for Q1 2024 was $148,000, up from $66,000 in Q1 2023, despite an increased net loss of $11.7 million.
Ovid Therapeutics Inc. will be participating in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024, at 3:00 p.m. ET. The company is focused on developing medicines for rare epilepsies and brain conditions. The event will be live webcasted and can be accessed through the Company’s website.
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