OVID Ovid Therapeutics Inc

Ovid Therapeutics Inc., (NASDAQ:OVID) a biopharmaceutical company committed to developing medicines for patients with rare neurological diseases, today announced that it will present preclinical data on TAK-935/OV935, a potent and highly selective cholesterol 24-hydroxylase inhibitor in development for the treatment of rare epileptic encephalopathies, at the Antiepileptic Drug and Device (AEDD) Trials XIV Conference taking place May 17-19, 2017, in Aventura (North Miami Beach), Fla. This will be the first public presentation of TAK-935 data.

Details of the oral presentation are listed below.

Presentation Session: Session XI: Drug Pipeline Title: TAK935/OV935, a Novel NMDA Modulator Under Development for Epileptic EncephalopathiesPresenter: Matthew During, M.D., D.Sc., Ovid TherapeuticsTime: May 19, 2017, 2:10 pm ETLocation: Turnberry Isle Miami Hotel

About TAK-935TAK-935, which is being studied in rare pediatric epilepsies, 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 24-S-hydroxycholesterol (24HC), which then exits the brain into the blood plasma circulation.i 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.ii Recent literature indicates CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel,iii implying its potential role in CNS diseases such as epilepsy. To our knowledge, TAK-935 is the only molecule with this mechanism of action in clinical development.

TAK-935 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 occupancy of TAK-935 in the brain.iv In addition, TAK-935’s effect on CH24H enzyme activity in the brain has been assessed by following measurable reductions in the plasma concentration of 24HC.

TAK-935 has completed four Phase 1 clinical studies,v,vi,vii,viii which have assessed tolerability and target engagement at doses which are believed to be therapeutically relevant.

About Ovid TherapeuticsOvid Therapeutics is a New York-based biopharmaceutical company developing therapies for patients with rare neurological disorders. Ovid’s drug candidate, OV101, is currently in development for the treatment of symptoms of Angelman syndrome and Fragile X syndrome. Ovid is also developing TAK-935/OV935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare epileptic encephalopathies.

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

Forward-Looking Statements

This press release includes certain disclosures which contain “forward-looking statements,” including, without limitation, statements regarding the clinical development and scope of clinical trials, the timing of reporting clinical data for Ovid’s product candidates, and the potential use of TAK-935/OV935 to treat epileptic encephalopathies. You can identify forward-looking statements because they contain words such as “will,” “believes” 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 are set forth in Ovid’s filings with the Securities and Exchange Commission, including its registration statement on Form S-1, as amended, under the caption “Risk Factors.” Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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i Russell DW, Halford RW, Ramirez DMO, Shah R, Kotti T. Cholesterol 24-hydroxylase: An enzyme of cholesterol turnover in the brain. Annu Rev Biochem. 2009;78:1017-1040.

ii Mehta A, Prabhakar M, Kumar P, Deshmukh R, Sharma PL. Excitotoxicity: bridge to various triggers in neurodegenerative disorders. Eur J Pharmacol. 2013;698(1-3):6-18.

iii Paul SM, Doherty JJ, Robichaud AJ, Belfort GM, Chow BY, Hammond RS, et al. The major brain cholesterol metabolite 24(S)-hydroxycholesterol is a potent allosteric modulator of N-methyl-D-aspartate receptors. J Neurosci. 2013;33(44):17290-300.

iv https://www.clinicaltrials.gov/ct2/show/NCT02497235?term=TAK-935&rank=1

v https://www.clinicaltrials.gov/ct2/show/NCT02497235?term=TAK-935&rank=1

vi https://www.clinicaltrials.gov/ct2/show/NCT02906813?term=TAK-935&rank=2

vii https://www.clinicaltrials.gov/ct2/show/NCT02201056?term=TAK-935&rank=3

viii https://www.clinicaltrials.gov/ct2/show/NCT02539134?term=TAK-935&rank=4

 

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

Media:
Pure Communications, Inc.
Katie Engleman, 910-509-3977
katie@purecommunicationsinc.com