Ovid Therapeutics to Present at the American Epilepsy Society (AES) 2020 Virtual Congress
November 23 2020 - 4:01PM
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
abstracts from the TAK-935/OV935 (soticlestat) clinical development
program in Dravet syndrome or Lennox-Gastaut syndrome (Phase 2
ELEKTRA study) and the OV101 (gaboxadol) clinical development
program in Angelman syndrome (Phase 2 STARS study), will be
presented at the American Epilepsy Society (AES) 2020 Virtual
Congress, taking place December 4-8, 2020.
“There remains significant unmet medical needs for the treatment
of Dravet, Lennox-Gastaut, and Angelman syndromes, all of which are
neurological conditions with highly impactful effects on
individuals, caregivers, and their families,” said Amit Rakhit, MD,
MBA, President and Chief Medical Officer at Ovid. “It is important
that we continue to analyze data from studies like ELEKTRA and
STARS, as we advance understanding of these conditions and work
towards our goal of addressing demonstrated gaps in treatment.”
Details of the presentations are as follows:
Title: Efficacy, safety, and tolerability of
soticlestat (TAK-935/OV935) as adjunctive therapy in pediatric
patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA);
Hahn, et al. Poster Number: #851
Title: Quantitative analysis of EEG signals in
STARS, a Phase 2 safety, tolerability, and exploratory efficacy
study of gaboxadol in adolescents and adults with Angelman
syndrome; Wang, et al.Poster Number: #49
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 in
development. 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 (DEEs). For more
information on Ovid, please visit www.ovidrx.com.
About OV935
(soticlestat)Soticlestat
is a potent, highly selective, first-in-class inhibitor of the
enzyme cholesterol 24-hydroxylase (CH24H), with the potential to
reduce seizure susceptibility and improve seizure control. CH24H is
predominantly expressed in the brain, where it converts cholesterol
into 24S-hydroxycholesterol (24HC) to adjust the homeostatic
balance of brain cholesterol. 24HC is a positive allosteric
modulator of the NMDA receptor and modulates glutamatergic
signaling associated with epilepsy. 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 that CH24H is involved in over-activation of the
glutamatergic pathway through modulation of the NMDA channel and
that increased expression of CH24H can disrupt the reuptake of
glutamate by astrocytes, resulting in epileptogenesis and
neurotoxicity. Inhibition of CH24H by soticlestat reduces the
neuronal levels of 24HC and may improve excitatory/inhibitory
balance of NMDA channel activity.
Ovid and Takeda recently announced positive
topline results from the randomized Phase 2 ELEKTRA
study of soticlestat in children with Dravet syndrome (DS) or
Lennox-Gastaut syndrome (LGS).
Takeda and Ovid are sharing in the development and
commercialization costs of soticlestat on a 50/50 basis, and if
successful, the companies will share in the profits on a 50/50
basis. Takeda will be responsible for commercialization
in Japan and has the option to be responsible for
commercialization in other countries in Asia and other
selected countries. Ovid will be responsible for clinical
development activities and commercialization of soticlestat
in the United
States, Europe, Canada and Israel. Under the
terms of the agreement, Takeda received equity in Ovid
and may be eligible to receive certain milestone payments based on
the advancement of soticlestat.
About OV101
(gaboxadol)OV101
(gaboxadol) is a delta (δ)-selective GABAA receptor agonist in
clinical development for the potential treatment of two rare
neurodevelopmental conditions: Angelman syndrome and Fragile X
syndrome. These receptors are thought to have a central role in
tonic inhibition, a key physiological process of the brain believed
to be a core pathophysiology underlying certain neurodevelopmental
disorders. We believe OV101 is the first and only investigational
drug to specifically target the disruption of tonic inhibition,
which is believed to be a central cause of many clinical deficits
in these disorders. OV101 has demonstrated in laboratory studies
and animal models to selectively activate the δ-subunit of
GABAA receptors and thereby modulate tonic inhibition.
Positive data from the Phase 2 STARS trial of OV101 in adults and
adolescents with Angelman syndrome was reported in 2018. Results of
a successful Phase 2 signal-finding trial of OV101 in individuals
with Fragile X syndrome (ROCKET) were reported in 2020. The Company
anticipates initial data from an ongoing pivotal Phase 3 trial in
Angelman syndrome (NEPTUNE) in Q4 2020. OV101 has received Rare
Pediatric Disease Designation from the FDA for the treatment of
Angelman syndrome and was granted Orphan Drug and Fast Track
designations for Angelman syndrome and Fragile X syndrome.
The European Commission (EC) has granted Orphan Drug
designation to OV101 for the treatment of Angelman syndrome. The
Company has licensed to Angelini Pharma the right to develop,
manufacture and commercialize OV101 for the treatment of Angelman
syndrome in the European Union and other countries in the
European Economic Area, and also in
Switzerland, Turkey, the United
Kingdom and Russia.
Forward-Looking StatementsThis press release
includes certain disclosures that contain “forward-looking
statements,” including, without limitation, statements regarding:
clinical and regulatory development of our programs, potential
benefits of OV101, OV935 and our other research programs and the
anticipated reporting schedule of clinical data and the potential
benefits. 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:Dan
Budwick1ABdan@1abmedia.com
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