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Ovid Therapeutics Announces OV935/TAK-935 Presentations at the American Epilepsy Society 72nd Annual Meeting

NEW YORK, Nov. 20, 2018 (GLOBE NEWSWIRE) -- 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 two poster presentations and one oral presentation on OV935/TAK-935 at the American Epilepsy Society (AES) 72nd Annual Meeting, taking place from November 30December 4, 2018, at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

“The oral presentation will report new preclinical work in a genetic seizure model – the Dravet syndrome mouse model – showing OV935’s potential impact on seizure incidence, frequency and severity and improvement in overall survival,” said Matthew During, M.D., D.Sc., founder and chief scientific officer of Ovid Therapeutics. “The Dravet mouse model data build upon our previously presented findings on survival benefit on the APP/PS1 transgenic mouse model. Collectively, our preclinical work continues to show the potential of OV935’s mechanism of action to make the brain more resistant to hyperexcitation and seizures.”

Details of the presentations are listed below.

Oral Presentation:
This presentation will also be presented as the poster listed below.

Title: TAK-935 Reduces Seizure Frequency and Severity and Prevents Premature Lethality in Scn1a+/- Dravet Mice
Abstract ID: #1.286
Session: Translational Research Platform Session C
Date and Time: Monday, December 3, 2018, 4:15 p.m. CT

Poster Presentations:
Location: Concourse Level in Hall B

Title: TAK-935 Reduces Seizure Frequency and Severity and Prevents Premature Lethality in Scn1a+/- Dravet Mice
Abstract ID: #1.286
Session: Poster Session 1
Date: Saturday, December 1, 2018

Title: Cognitive Assessment After Multiple Ascending Doses of TAK-935 in Healthy Subjects
Abstract ID: #1.301
Session: Poster Session 1
Date: Saturday, December 1, 2018

About Investigational OV935/TAK-935
OV935 is a potent, highly-selective, potential first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as an anti-epileptic drug (AED) as part of a collaboration with Takeda Pharmaceutical Company Limited (“Takeda”).

CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24-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 CH24H 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. Ovid and Takeda believe that OV935’s novel mechanism of action may potentially treat rare epilepsies by inhibiting CH24H to decrease 24HC levels, effectively decreasing glutamate hyperactivity. To Ovid and Takeda’s knowledge, OV935 is the only molecule with this mechanism of action in clinical development. OV935 is an investigational drug, not approved for commercial use.

OV935 has successfully completed four Phase 1 clinical studies, which have assessed tolerability, pharmacokinetics (PK) and target engagement at doses believed to be therapeutically relevant. In preclinical models, a novel proprietary PET ligand was used to determine target occupancy of OV935 in the brain. 

The United States Food and Drug Administration (FDA) has granted orphan drug designation to OV935 for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome (LGS).

All patients have completed their last visit in a Phase 1b/2a randomized, double-blind, clinical trial designed to look at the safety, tolerability, PK, and pharmacodynamics of OV935 in adult patients with developmental and epileptic encephalopathies (DEE). Results from the trial are expected in the fourth quarter of 2018.

About Ovid Therapeutics

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company’s lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda for the treatment of rare DEE.

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

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding (i) the timing and reporting of data from the Phase 1b/2a randomized, double-blind, clinical trial designed to look at the safety, tolerability, PK, and pharmacodynamics of OV935 in adult patients with developmental and epileptic encephalopathies (DEE), and (ii) the likelihood that OV935’s novel mechanism of action may be effective to treat rare epilepsies, and to improve overall survival.  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, 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.

Contacts:

Investors:
Lora Pike  
Ovid Therapeutics Inc.
lpike@ovidrx.com

Media:
Jerica Pitts
W2O Group
jpitts@w2ogroup.com
(312) 858-3469 

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Ovid Therapeutics Inc.