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Ovid Therapeutics to Present at the 12th International Epilepsy ColloquiumNEW YORK, May 23, 2019 /PRNewswire/ -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, will present data on safety, tolerability, exploratory and secondary outcomes from the Phase 1b/2a clinical trial of OV935/TAK-935 in adult patients with developmental and epileptic encephalopathies (DEE). The data will be presented as a poster at the 12th International Epilepsy Colloquium (IEC), taking place May 26-28 in Lyon, France. "DEE refers to a group of rare conditions characterized by cognitive impairment and severe epilepsy.1 Each of these conditions can worsen over time and cause significant morbidities for patients and their families so there is an urgent need for new medicines in this area," said Amit Rakhit, MD, MBA, Chief Medical Officer and Head of Research & Development at Ovid. "Together with Takeda, we believe that OV935 may have the potential to treat rare epilepsies and are committed to making a difference for patients living with these diseases." The randomized, double blind, placebo-controlled Phase 1b/2a clinical trial achieved its primary endpoint of safety and tolerability and showed OV935 was generally well tolerated. During the open-label period, 11 patients (68.8%) experienced a treatment-emergent adverse event (TEAE), of which the majority were mild. There were five serious TEAEs, all seizure cluster related. Overall, the data are consistent with a favorable safety and tolerability profile and support the continued clinical development of OV935. Ovid is committed to grounding innovative research by first understanding biological pathways and their central role in rare neurological disorders in order to develop clinically-relevant endpoints that measure the efficacy of investigational treatments and deliver tangible patient benefits. Exploratory endpoints in the Phase 1b/2a trial included changes in seizure frequency and plasma 24S-hydroxycholesterol (24HC) levels. OV935 showed initial evidence of potential efficacy with a reduction in seizure frequency and a reduction in mean 24HC levels. This preliminary evidence suggests that plasma 24HC may be a promising biomarker for assessing treatment outcome and disease management. Details of the presentation are listed below. Title: A phase 1b/2a study of TAK-935 (OV935) as adjunctive therapy in patients with developmental and epileptic encephalopathies (DEE) Previously announced by Ovid in its December 17, 2018 press release, these results were also presented as an invited speakership at the 15th Antiepileptic Drug and Device Trials Conference, May 22-24, Miami, Fl. The IEC presentation and the invited speakership demonstrate a burgeoning interest in rare epilepsies and the hope that OV935 might be a potential treatment option. About Developmental and Epileptic Encephalopathies These epilepsies cause significant morbidities for patients beyond what might be expected from the known underlying pathology alone and can worsen over time. Developmental and epileptic encephalopathies typically present early in life and are often associated with severe cognitive and developmental impairment in addition to frequent treatment-resistant seizures throughout the person's lifetime. These disorders vary in age of onset, developmental outcomes, etiologies, neuropsychological deficits, electroencephalographic (EEG) patterns, seizure types, and prognosis. Despite the availability of medicines for epilepsy, few treatment options are available for epileptic encephalopathies, and novel therapies are needed. About Investigational OV935/TAK-935 The United States Food and Drug Administration (FDA) has granted orphan drug designation to OV935 for the treatment of both Dravet syndrome and LGS. About the Ovid/Takeda Collaboration About Ovid Therapeutics 1Source: I.E. Scheffer, S. Berkovic, G. Capovilla, et al. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia; 58 (2017): 512-521. https://onlinelibrary.wiley.com/doi/full/10.1111/epi.13709 For more information on Ovid, please visit http://www.ovidrx.com/. Forward-Looking Statements
View original content to download multimedia:http://www.prnewswire.com/news-releases/ovid-therapeutics-to-present-at-the-12th-international-epilepsy-colloquium-300856314.html SOURCE Ovid Therapeutics Inc. |