CINCINNATI, July 11, 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 several
presentations related to the OV101 Fragile X syndrome program will be given this week at the 16th NFXF International
Fragile X conference taking place in Cincinnati, Ohio from July 11 – 15, 2018.
OV101 is a novel delta (δ)-selective GABAA receptor agonist that targets the disruption of tonic
inhibition, a central physiological process of the brain that is thought to be the underlying cause of Fragile X syndrome and other
neurodevelopmental disorders. It is believed that OV101 is the first investigational medicine to target the disruption of tonic
inhibition.
Details of the presentations are listed below.
Oral presentation
Title: Fragile X Syndrome: Patient Partnership in Clinical Drug Development
Session: Industry Updates
Date and Time: Thursday, July 12, 2018, 4:30 – 5:30 p.m. CT
Poster presentations
Title: Development of a Conceptual Model to Inform a Clinical Outcome Assessment Strategy in
Adolescents and Young Adults with Fragile X Syndrome
Poster ID: 294
Date and Time: Friday, July 13, 2018, 3:45 – 7:00 p.m. CT
Title: Clinical Unmet Needs and Burden in Fragile X Syndrome: Results of a Targeted Literature
Review
Poster ID: 425
Date and Time: Friday, July 13, 2018, 3:45 – 7:00 p.m. CT
Title: A Literature Review of the Economic Burden of Fragile X Syndrome
Poster ID: 429
Date and Time: Friday, July 13, 2018, 3:45 – 7:00 p.m. CT
About Fragile X Syndrome
Fragile X syndrome is the most common inherited form of intellectual disability and autism, with a prevalence of 1 in
3,600 to 4,000 males and 1 in 4,000 to 6,000 females in the United States. Individuals with Fragile X syndrome often have a range
of behavioral challenges, such as cognitive impairment, anxiety, mood swings, hyperactivity, attention deficit, poor sleep,
self-injury and heightened sensitivity to various stimuli, such as sound. Additionally, individuals with Fragile X syndrome are
prone to comorbid medical issues including seizures and sleep disturbance. Fragile X syndrome results from mutations in the FMR1
gene, which blocks expression of the Fragile X Mental Retardation Protein (FMRP), an important protein in GABA synthesis. There are
no FDA-approved therapies for Fragile X syndrome, and treatment primarily consists of behavioral interventions and pharmacologic
management of symptoms.
In studies of individuals with Fragile X syndrome and in experimental models, extrasynaptic GABA levels are
abnormally reduced, and there is also dysregulation of GABA receptors. This ultimately contributes to a decrease in tonic
inhibition, causing the brain to become inundated with signals and lose the ability to separate background noise from critical
information.
About OV101
OV101 (gaboxadol) is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first
investigational medicine 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 (with
more than 1000 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 both the treatment of Angelman
syndrome and Fragile X syndrome. The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating
Angelman syndrome and Fragile X syndrome using OV101. The issued patents expire in 2035.
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 people with rare neurological disorders. Ovid has a broad pipeline of 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 TAK-935/OV935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of
rare developmental and epileptic encephalopathies (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) progress, timing, scope and results of clinical trials for Ovid’s product candidates, and (ii) the
potential clinical benefit of OV101 to treat patients with Fragile X. 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 Quarterly Report on Form 10-Q for the period ended March 31, 2018 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.
Senior Director, Investor Relations & Public Relations
lpike@ovidrx.com
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Media:
W2O Group
Kelly Boothe, Ph.D.
+1-415-946-1076
kboothe@w2ogroup.com
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