Ovid Therapeutics to Present at the Child Neurology Society/International Child Neurology Association (CNS/ICNA) Virtual Cong...
October 12 2020 - 7:00AM
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
four abstracts from the OV101 (gaboxadol) clinical development
program will be presented at the Child Neurology
Society/International Child Neurology Association (CNS/ICNA) 2020
Virtual Congress, taking place October 12 – October 23, 2020.
The presentations include additional data and analyses from the
Phase 2 ROCKET clinical trial of OV101 in individuals with Fragile
X Syndrome; data on seizure and EEG outcomes from the Phase 2 STARS
clinical trial in individuals with Angelman Syndrome; encore
presentations of a study of caregiver insights in Angelman
Syndrome; and the utility of the Clinical Global Impression (CGI)
scale for studying outcomes in neurodevelopmental conditions.
“Ovid is passionately committed to the development of OV101 to
address the significant unmet medical need in individuals with both
Angelman and Fragile X Syndromes – two neurological conditions with
tremendous caregiver and family impact with no approved treatment
options for either,” said Amit Rakhit, MD, MBA, President and Chief
Medical Officer at Ovid. “These data will contribute to evolving
scientific exchange and advancing discussion around
neurodevelopmental conditions, caregiver concerns, and the urgency
to develop new medicines for these conditions.”
Details of the presentations are as follows:
Title: Caregiver Insight on the Core Domains in
Angelman Syndrome; Adera, et alPoster Number:
#587
Title: The Phase 2a ROCKET Trial Investigating
Gaboxadol (OV101) in Adolescents and Young Adults with Fragile X
Syndrome; Berry-Kravis, et alPoster Number:
#676
Title: The Adaptation and Utility of the
Clinical Global Impression Scale for Studying Treatment Outcomes in
Neurodevelopmental Conditions; Jaeger, et alPoster
Number: #46
Title: STARS, a Phase 2 Safety, Tolerability,
and Exploratory Efficacy Study of Gaboxadol in Adolescents and
Adults with Angelman Syndrome: Seizure and EEG Outcomes; Wang, et
alPoster Number: #588
About Ovid TherapeuticsOvid Therapeutics
Inc. 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
most advanced investigational medicine, OV101 (gaboxadol), is
currently in clinical development for the treatment of Angelman
syndrome and Fragile X syndrome. Ovid is also developing OV935
(soticlestat) in collaboration with Takeda Pharmaceutical Company
Limited for the potential treatment of rare developmental and
epileptic encephalopathies (DEE). For more information on Ovid,
please visit www.ovidrx.com.
About OV101 (gaboxadol)OV101 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 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 modulation of tonic inhibition.
Ovid is developing OV101 for the treatment of Angelman syndrome
and Fragile X syndrome to potentially restore tonic inhibition and
thereby address several core symptoms of these conditions. In both
these syndromes, the underlying pathophysiology includes disruption
of tonic inhibition modulated through the δ-subunit of
GABAA receptors. In preclinical studies, it was observed that
OV101 improved symptoms of Angelman syndrome and Fragile X
syndrome. This compound has also previously been tested in more
than 4,000 patients (more than 1,000 patient-years of exposure) and
was observed to have favorable safety and bioavailability profiles.
Ovid is conducting a pivotal Phase 3 clinical trial with OV101 in
Angelman syndrome (NEPTUNE) and has completed a Phase 2
signal-finding clinical trial with OV101 in Fragile X syndrome
(ROCKET).
OV101 has received Rare Pediatric Disease Designation from the
FDA for the treatment of Angelman syndrome. The FDA has also
granted Orphan Drug and Fast Track designations for OV101 for both
the treatment of Angelman syndrome and Fragile X syndrome. In
addition, the European Commission (EC) has granted orphan
drug designation to OV101 for the treatment of Angelman 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
without regulatory extensions.
Forward-Looking StatementsThis press release
includes certain disclosures that contain “forward-looking
statements,” including, without limitation, statements regarding
the potential benefits, clinical and regulatory development, the
likelihood that data will support future development, and the
association of data with treatment outcomes. You can identify
forward-looking statements because they contain words such as
“will,” “appears,” “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 include uncertainties in the development and regulatory
approval processes, and the fact that initial data from clinical
trials may not be indicative, and are not guarantees, of the final
results of the clinical trials and are subject to the risk that one
or more of the clinical outcomes may materially change as patient
enrollment continues and/or more patient data become available.
Additional risks 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.” Such risks may be amplified by
the COVID-19 pandemic and its potential impact on Ovid’s business
and the global economy. 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 and Media:Ovid Therapeutics
Inc.Investor Relations & Public Relationsirpr@ovidrx.com
OR
Investors:Argot PartnersMaeve
Conneighton212-600-1902ovid@argotpartners.com
Media:Argot PartnersJoshua R.
Mansbach212-600-1902ovid@argotpartners.com
OR
Media:Dan
Budwick1ABdan@1abmedia.com
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