-
Cornerstone of Robust Clinical Development Strategy
for Potential First-in-Class CH24H Modulator
-
Ovid Therapeutics Inc. (NASDAQ:OVID), a biopharmaceutical company
committed to developing medicines for patients with rare
neurological disorders, today announced it has randomized the first
patient in its Phase 1b/2a clinical trial of TAK-935, also known as
OV935, in collaboration with Takeda Pharmaceutical Company Limited.
This marks the second program Ovid has advanced into Phase 2
clinical development this year.
Takeda and Ovid formed a global collaboration focused on the
clinical development and commercialization of TAK-935/OV935, a
potent and highly selective cholesterol 24-hydroxylase (CH24H)
inhibitor, being investigated in adults with developmental and/or
epileptic encephalopathies in January 2017.
“We are excited to achieve this important milestone as this is
the first clinical trial in our collaboration with Ovid and
TAK-935/OV935 is the first CH24H inhibitor in clinical
development,” said Dr. Emiliangelo Ratti, head of Takeda’s Central
Nervous System Therapeutic Area Unit. “While there are many
treatments available for epilepsy, few therapeutic options exist
for patients with developmental and/or epileptic encephalopathies,
which cause intractable seizures that are often associated with
cognitive, neurologic and behavioral symptoms. Our collaboration
with Ovid is geared to leverage each company’s strengths to jointly
develop this investigational medicine for people living with rare
epilepsies.”
“We believe that TAK-935/OV935 has the potential to target the
increased pro-epileptic signaling that occurs in developmental
and/or epileptic encephalopathies and provide a treatment for
people with rare epilepsies who currently do not have sufficient
options,” said Amit Rakhit, M.D., MBA, chief medical and portfolio
management officer of Ovid Therapeutics. “This trial is the
beginning of a planned broader development program for
TAK-935/OV935. We intend to investigate TAK-935/OV935 in younger
populations because rare epilepsies, such as Dravet syndrome,
Lennox-Gastaut syndrome and Tuberous Sclerosis Complex, are
diagnosed early in life and this may provide an opportunity to
intervene early in the disease course.”
Data from the Phase 1b/2a trial in adults with developmental
and/or epileptic encephalopathies, which are types of rare
epilepsies that share similar clinical manifestations, is
anticipated in 2018. As part of the broader development program,
Ovid and Takeda also plan to study the role of
24-S-hydroxycholesterol (24HC) as a peripheral biomarker that can
inform future clinical trial designs and help clinicians
individualize the use of this therapy.
TAK-935/OV935 has the potential to become a first-in-class CH24H
inhibitor and is believed to modulate the N-Methyl-D-Aspartate
(NMDA) receptor, which has been implicated in several neurologic
disorders, including rare epilepsies. TAK-935/OV935 has been tested
in four Phase 1 clinical trials involving 86 healthy volunteers and
has been found to be well tolerated without clinically significant
safety findings. Data from multiple preclinical models indicate
that TAK-935/OV935 may affect both seizure intensity and
frequency.
About the Phase 1b/2a TrialThe randomized,
double-blind, placebo-controlled, dose-escalation Phase 1b/2a
clinical trial will enroll approximately 20 adult patients with
developmental and/or epileptic encephalopathies, including Dravet
Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex.
The multicenter trial will include an initial one-month baseline
period followed by a one-month double-blind, dose-escalation phase.
Participants will have the option to continue for an additional
two-month open-label extension phase. The primary endpoint of the
study is to characterize the safety and tolerability of
TAK-935/OV935. Secondary endpoints include assessment of standard
safety laboratory values and evaluation of pharmacokinetics.
Learn more about the trial at http://www.clinicaltrials.gov.
About Rare EpilepsiesDevelopmental and/or
epileptic encephalopathies are a group of rare epilepsies that
cause significant morbidities for patients and their families
beyond what might be expected from the underlying pathology alone
and can worsen over time. Developmental and/or epileptic
encephalopathies typically present early in life and are often
associated with severe cognitive and developmental impairment in
addition to frequent seizures throughout the
person’s lifetime. These disorders vary in their age of onset,
developmental outcome, etiologies, neuropsychological deficits,
electroencephalographic (EEG) patterns, seizure types and
prognosis.
Despite the availability of medicines for epilepsy, few
treatment options are available for epileptic encephalopathies, and
novel therapies are needed.
About TAK-935/OV935TAK-935/OV935, which is
being studied in rare epilepsies, is a potent, highly-selective,
first-in-class inhibitor of the enzyme CH24H. CH24H is
predominantly expressed in the brain, where it plays a central role
in cholesterol homeostasis. CH24H converts cholesterol to 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. To Ovid’s knowledge,
TAK-935/OV935 is the only molecule with this mechanism of action in
clinical development.
TAK-935/OV935 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/OV935 in the brain. In addition,
TAK-935/OV935’s effect on CH24H enzyme activity in the brain has
been assessed by following measurable reductions in the plasma
concentration of 24HC.
TAK-935/OV935 has completed four Phase 1 clinical studies, which
have assessed tolerability and target engagement at doses believed
to be therapeutically relevant. TAK-935/OV935 is being co-developed
by Ovid and Takeda Pharmaceutical Company Limited.
About Ovid TherapeuticsOvid Therapeutics
(NASDAQ:OVID) is a New York-based biopharmaceutical company using
its BoldMedicine™ approach to develop therapies that transform the
lives of patients with rare neurological disorders. Ovid’s drug
candidate, OV101, is currently in development for the treatment of
Angelman syndrome and Fragile X syndrome. Ovid has initiated the
Phase 2 STARS trial of OV101 in adults with Angelman syndrome and a
Phase 1 trial in adolescents with Angelman syndrome or Fragile X
syndrome. Ovid is also developing OV935 in collaboration with
Takeda Pharmaceutical Company Limited for the treatment of rare
epileptic encephalopathies and has initiated a Phase 1b/2a trial of
OV935.
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
progress, timing, scope and results of clinical trials for Ovid’s
product candidates, the reporting of clinical data regarding Ovid’s
product candidates, and the potential use of TAK-935/OV935 to treat
rare epilepsies. 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 quarter ended June 30, 2017, 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:
Burns McClellan
Steve Klass, 212-213-0006
Sklass@burnsmc.com
Media:
Pure Communications, Inc.
Katie Engleman, 910-509-3977
katie@purecommunicationsinc.com
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From Apr 2023 to Apr 2024