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Ovid Therapeutics Announces Multiple Poster Presentations of OV101 and TAK-935/OV935 at the American Academy of Neurology 70th Annual Meeting

NEW YORK – March 1, 2018 – Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced that it will present five poster presentations on OV101 and six poster presentations on TAK-935/OV935 at the American Academy of Neurology (AAN) 70th Annual Meeting, taking place from April 21-27, 2018, at the Los Angeles Convention Center in Los Angeles, California.

Details of the poster presentations are listed below.

OV101

Title: Gaboxadol Normalizes Behavioral Abnormalities in a Mouse Model of Fragile X Syndrome
Poster ID: 323
Session: Poster Session I
Date and Time: Sunday, April 22, 2018, 11:30 a.m. – 5:30 p.m. PT

Corrected Title: STARS: A Phase 2 Adult Angelman Syndrome Clinical Trial: Randomized, Double-blind, Safety and Efficacy Study of Gaboxadol
Poster ID: 302
Session: Poster Session III
Date and Time: Tuesday, April 24, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Healthcare and Medical Service Utilization Among Patients With Angelman Syndrome By Molecular Subtype: Results From The AS-NHS Study
Poster ID: 307
Session: Poster Session III
Date and Time: Tuesday, April 24, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Clinical Unmet Needs and Burden in Fragile X Syndrome: Results of a Targeted Literature Review
Abstract ID: 314
Session: Poster Session III
Date and Time: Tuesday, April 24, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: A Literature Review of the Economic Burden of Fragile X Syndrome
Abstract ID: 319
Session: Poster Session III
Date and Time: Tuesday, April 24, 2018, 11:30 a.m. – 7:00 p.m. PT

TAK-935/OV935

Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of TAK-935 in Healthy Subjects
Poster ID: 262
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Evaluation of pharmacodynamic effects of cholesterol 24-hydroxylase inhibitor TAK-935 and its target engagement in animals.
Poster ID: 263
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Inhibition of Cholesterol 24-hydroxylase is a Novel Pharmacological Strategy for Epilepsy Treatment
Poster ID: 264
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Clinical Trial Simulations for Paediatric Dose Selection Using a Pharmacokinetic/Enzyme- Occupancy/Pharmacodynamic Model of TAK-935, a Cholesterol 24S-hydroxylase Inhibitor
Poster ID: 265
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: A Phase 1b/2a Study to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects with Developmental and/or Epileptic Encephalopathies
Poster ID: 266
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of TAK 935 in Healthy Subjects
Poster ID: 267
Session: Poster Session V
Date and Time: Thursday, April 26, 2018, 11:30 a.m. – 7:00 p.m. PT

About OV101 
OV101 (gaboxadol) is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first investigational drug to specifically target the disruption of tonic inhibition, a central physiological process of the brain that is thought to be the underlying cause of certain neurodevelopmental disorders. OV101 has been demonstrated in laboratory studies and animal models to selectively activate the δ-subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and thereby impact neuronal activity through tonic inhibition.  

Ovid is developing OV101 for the treatment of Angelman syndrome and Fragile X syndrome to potentially restore tonic inhibition and relieve several of the symptoms of these disorders. In preclinical studies, it was observed that OV101 improved symptoms of Angelman syndrome and Fragile X syndrome. Gaboxadol has previously been tested in over 4,000 patients (approximately 950 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles.  

The FDA has granted orphan drug and Fast Track designations for OV101 for the treatment of Angelman syndrome and orphan drug designation for the treatment of Fragile X syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome using OV101. The issued patents expire in 2035 for Angelman syndrome.

About TAK-935/OV935
TAK-935/OV935, which is being studied in developmental and epileptic encephalopathies, is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24S-hydroxycholesterol (24HC), which then exits the brain into the blood plasma circulation. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity. Recent literature indicates 24HC is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel, implying its potential role in central nervous system diseases such as epilepsy. To Ovid and Takeda’s knowledge, TAK-935/OV935 is the only molecule with this mechanism of action in clinical development.

TAK-935/OV935 has been tested in preclinical models to provide data to support the advancement of the drug into human clinical studies in patients suffering from rare epilepsy syndromes. A novel proprietary PET ligand, developed by Takeda and Molecular Neuroimaging, LLC (MNI), has been used to determine target enzyme occupancy of TAK-935/OV935 in the brain. In addition, the effect of TAK-935/OV935 on CH24H enzyme activity in the brain has been assessed by following measurable reductions in the plasma concentration of 24HC.

TAK-935/OV935 has completed four Phase 1 clinical studies, which have assessed tolerability and target engagement at doses believed to be therapeutically relevant. The FDA has granted orphan drug designation for TAK-935/OV935 for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome. TAK-935/OV935 is being co-developed by Ovid and Takeda Pharmaceutical Company Limited.

About Ovid Therapeutics
Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop therapies that transform the lives of patients with rare neurological disorders. Ovid’s drug candidate, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid initiated the Phase 2 STARS trial of OV101 in people with Angelman syndrome in 2017 and completed a Phase 1 trial in adolescents with Angelman syndrome or Fragile X syndrome. Ovid is also developing OV935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of epileptic encephalopathies and in 2017 initiated a Phase 1b/2a trial of OV935.

For more information on Ovid, please visit http://www.ovidrx.com/.

Contacts
Investors:
Burns McClellan
Steve Klass, 212-213-0006
Sklass@burnsmc.com

Media:
W2O pure
Katie Engleman, 910-509-3977
kengleman@w2ogroup.com