− Primary endpoint achieved, demonstrating a statistically
significant reduction of seizures from baseline compared to placebo
(p=0.0007) in the combined Dravet syndrome and Lennox-Gastaut
syndrome study population
− Statistically significant reduction in seizure frequency
from baseline in Dravet syndrome cohort compared to placebo
(p=0.0007); based on strong efficacy results, Takeda and Ovid plan
to initiate a Phase 3 registrational program of soticlestat in
Dravet syndrome
− Data from Lennox-Gastaut syndrome cohort demonstrated
numeric reductions in seizure frequency compared to placebo but did
not achieve statistical significance (p=0.1279); data analysis
ongoing for the Lennox-Gastaut syndrome patients
− Soticlestat was well-tolerated and demonstrated a safety
profile consistent with the findings of previous studies with no
new safety signals identified
− Ovid to host conference call and webcast today at 8:00 a.m.
EDT
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
(“Takeda”) and Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a
biopharmaceutical company committed to developing medicines that
transform the lives of people with rare neurological diseases,
today announced positive topline results from the randomized Phase
2 ELEKTRA study of soticlestat in children with Dravet syndrome
(DS) or Lennox-Gastaut syndrome (LGS). Soticlestat is a potent,
highly selective, oral, first-in-class inhibitor of the enzyme
cholesterol 24-hydroxylase (CH24H). It is being investigated by
Ovid and Takeda for the treatment of rare developmental and
epileptic encephalopathies (DEEs), a group of highly refractory
epilepsy syndromes including DS and LGS.
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The ELEKTRA study achieved its primary endpoint with high
statistical significance, demonstrating a 27.8% median reduction
from baseline in convulsive seizure (DS) and drop seizure (LGS)
frequency compared to a 3.1% median increase in patients taking
placebo during the 12-week maintenance period (median
placebo-adjusted reduction=30.5%; p=0.0007, based on the efficacy
analysis set of 120 patients with seizure data in the maintenance
period). In addition, DS and LGS patients treated with soticlestat
demonstrated a 29.8% median reduction in convulsive seizure (DS)
and drop seizure (LGS) frequency compared to 0.0% change in median
seizure frequency in patients taking placebo during the full
20-week treatment period (titration plus maintenance) of the
ELEKTRA study (placebo-adjusted reduction=25.1%; p=0.0024).
In the ELEKTRA DS cohort (n=51), patients treated with
soticlestat demonstrated a 33.8% median reduction in convulsive
seizure frequency compared to a 7.0% median increase in patients
taking placebo during the full 20-week treatment period of the
study (median placebo-adjusted reduction in seizure frequency is
46.0%; p=0.0007). Based on these data, the companies plan to meet
with regulatory authorities to discuss initiation of a Phase 3
registrational program for soticlestat in patients with DS.
In the ELEKTRA LGS cohort (n=88), patients treated with
soticlestat demonstrated a 20.6% median reduction in drop seizure
frequency compared to a 6.0.% median reduction in patients taking
placebo during the full 20-week treatment period of the study
(median placebo-adjusted reduction in seizure frequency is 14.8%;
p=0.1279). Additional analyses are being conducted to better
understand the potential next steps for the development of
soticlestat in this highly heterogenous patient population.
Soticlestat was generally well-tolerated in the ELEKTRA study
and demonstrated a safety profile consistent with those of previous
studies, with no new safety signals identified. All patients who
completed the ELEKTRA study elected to enroll into the ENDYMION
open-label extension study and findings from ENDYMION are also
reported today.
“We are extremely encouraged by these results, which show a
clear statistically significant reduction of seizures in Dravet
syndrome patients treated with soticlestat, as well as a trend for
seizure reduction in Lennox-Gastaut patients,” said Amit Rakhit,
M.D., MBA, President and Chief Medical Officer of Ovid. “We look
forward to continuing our collaboration with Takeda to initiate a
Phase 3 registrational program for soticlestat in patients with DS,
while continuing to analyze the data from patients with LGS in the
ELEKTRA and ENDYMION studies to define potential next steps. We
also expect to report data from the open-label Phase 2 ARCADE study
with soticlestat in patients with CDKL5 deficiency disorder and
Dup15q syndrome, two other types of highly-refractory DEEs, later
this quarter.”
“It is exciting to see these positive results and to advance
soticlestat into late stage clinical development -- initially for
the potential treatment of children with Dravet syndrome who need
more options to manage treatment-resistant seizures,” said Sarah
Sheikh, M.D., M.Sc., MRCP, Head, Neuroscience Therapeutic Area Unit
at Takeda. “Soticlestat and its novel mechanism of action were
discovered at Takeda and we are enthusiastic about continuing to
advance the science and clinical programs as one aligned team, in
strong partnership with Ovid Therapeutics.”
“Children with developmental epileptic encephalopathies like DS
and LGS need more options to manage their treatment-resistant
seizures,” said Dr. Cecil Hahn, M.D., MPH, a Child Neurologist at
The Hospital for Sick Children and Associate Professor of
Pediatrics at the University of Toronto. “The results of the
ELEKTRA study are very promising, particularly for children with DS
and represent a clinically significant reduction in seizure burden.
Moreover, soticlestat was well-tolerated in this study."
Phase 2 ELEKTRA Study Design and Patient Baseline
Demographics
ELEKTRA was an international, multi-center, randomized,
double-blind, placebo-controlled study designed to evaluate
treatment with soticlestat in pediatric patients, aged 2 to 17
years, with highly refractory epileptic seizures associated with DS
(convulsive seizures) or LGS (drop seizures). The study consisted
of a four- to six-week screening period to establish baseline
seizure frequency, followed by a 20-week double-blind treatment
period, including an 8-week dose optimization period and a 12-week
maintenance period. During the 8-week dose optimization period,
patients were titrated from 100mg twice daily (BID), to 200mg BID
to 300mg BID (mg/kg dosing for <60 kg) of orally administered
soticlestat.
A total of 141 patients were enrolled in ELEKTRA and 126
completed the study. A modified intent-to-treat (mITT) analysis of
139 patients was performed to evaluate the efficacy endpoints,
which includes any patient who enrolled in the study and received
at least one dose of study drug. Patients in the study were allowed
to be on one to four concomitant anti-epileptic drugs (AEDs), with
the majority of patients concomitantly treated with at least three
AEDs. The most common AEDs taken by the patients were valproate,
clobazam, levetiracetam and topiramate.
Phase 2 ELEKTRA Topline Efficacy Results
The study achieved its primary endpoint, demonstrating a 27.8%
median reduction from baseline in convulsive seizure (DS) and drop
seizure (LGS) frequency compared to a 3.1% median increase in
patients on placebo during the 12-week maintenance period (median
placebo-adjusted reduction=30.5%; p=0.0007, based on the efficacy
analysis set of 120 patients with seizure data in the maintenance
period). During the full 20-week treatment period of the mITT DS
patient population, the median percent change from baseline was a
33.8% decrease in seizure frequency compared to a 7.0% increase in
seizure frequency for patients receiving placebo (median
placebo-adjusted reduction=46.0%; p=0.0007). During the full
treatment period of the mITT LGS patient population, the median
percent change from baseline was a 20.6% decrease in seizure
frequency compared to a 6.0% decrease in patients receiving placebo
(median placebo-adjusted reduction=14.8%; p=0.1279).
Phase 2 ELEKTRA Topline Safety Results
Soticlestat was well tolerated in this study. These findings
were consistent with previous studies and no new safety signals
were identified. The incidence of treatment emergent adverse events
was similar in both the treatment and placebo groups with 57
(80.3%) of soticlestat patients experiencing at least one treatment
emergent adverse event compared to 52 (74.3%) placebo patients. The
most frequent treatment emergent adverse events reported in
soticlestat-treated patients with ≥5% difference from placebo were
lethargy and constipation. The incidence of serious adverse events
was similar in both soticlestat and placebo groups, with 11 (15.5%)
in soticlestat experiencing at least one treatment emergent serious
adverse event compared to 13 (18.6%) in placebo. There were no
deaths reported.
ENDYMION Open-Label Extension Study Update
All patients who completed the ELEKTRA trial elected to roll
over into the ENDYMION open-label extension study. The primary
objective of ENDYMION is to assess the long-term safety and
tolerability of soticlestat over four years of treatment in
patients with rare epilepsies and, secondarily, to evaluate the
effect of soticlestat on seizure frequency over time.
Data from the ELEKTRA patients who have rolled over into the
ENDYMION study are supportive of results in the core study. The
data indicate maintenance of effect over 6 months in those patients
originally randomized to soticlestat, and similarly reduced seizure
frequency as compared to baseline in those patients previously
assigned to the placebo arm. No new safety signals were identified
in ENDYMION.
About Soticlestat (TAK-935/OV935)
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.
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 Dravet Syndrome and Lennox-Gastaut Syndrome
Dravet syndrome and Lennox-Gastaut syndrome are types of
developmental and epileptic encephalopathies (DEEs), a
heterogeneous group of rare epilepsy syndromes. Dravet and
Lennox-Gastaut syndrome typically become apparent during infancy or
early childhood and are highly refractory to many antiseizure
medications.
Dravet syndrome is most commonly caused by a genetic mutation in
the SCN1A gene and affects approximately 1 in 15,000 to 1 in 21,000
people in the United States. Dravet syndrome is characterized by
prolonged focal seizures that can evolve to convulsive tonic-clonic
seizures. Children with Dravet syndrome experience developmental
disabilities as seizures increase. Other common symptoms include
changes in appetite, difficulty balancing and a crouched gait when
walking.
Lennox-Gastaut syndrome is estimated to affect approximately 1
in 11,000 people in the United States. Lennox-Gastaut syndrome is a
heterogeneous condition and characterized by several different
types of seizures, most commonly atonic (drop), tonic and atypical
absence seizures. Children with Lennox-Gastaut syndrome may also
develop cognitive dysfunction, delays in reaching developmental
milestones and behavioral problems. Lennox-Gastaut syndrome can be
caused by a variety of underlying conditions, but in some cases no
cause can be identified.
Ovid Conference Call and Webcast Information
Ovid Therapeutics will host a live conference call and webcast
today at 8:00 a.m. Eastern Time. The live webcast can be accessed
by visiting the Investors section of the Company’s website at
investors.ovidrx.com. Alternatively, please call 866-830-1640
(U.S.) or 210-874-7820 (international) to listen to the live
conference call. The conference ID number for the live call is
7926217. A replay of the webcast will be available on the Company’s
website following the live conference call.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a
global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to bringing Better Health and a
Brighter Future to patients by translating science into
highly-innovative medicines. Takeda focuses its R&D efforts on
four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and
Gastroenterology (GI). We also make targeted R&D investments in
Plasma-Derived Therapies and Vaccines. We are focusing on
developing highly innovative medicines that contribute to making a
difference in people's lives by advancing the frontier of new
treatment options and leveraging our enhanced collaborative R&D
engine and capabilities to create a robust, modality-diverse
pipeline. Our employees are committed to improving quality of life
for patients and to working with our partners in health care in
approximately 80 countries.
For more information, visit https://www.takeda.com.
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Takeda Forward-Looking Statements
This press release and any materials distributed in connection
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position and results of operations, including estimates, forecasts,
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“ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”,
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about many important factors, including the following, which could
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the ability to divest assets that are not core to Takeda’s
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factors identified in Takeda’s most recent Annual Report on Form
20-F and Takeda’s other reports filed with the U.S. Securities and
Exchange Commission, available on Takeda’s website at:
https://www.takeda.com/investors/reports/sec-filings/ or at
www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
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law or stock exchange rule. Past performance is not an indicator of
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forecast, guarantee or projection of Takeda’s future results.
About Ovid Therapeutics
Ovid 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.
Ovid Forward-Looking Statements
This press release includes certain disclosures that contain
“forward-looking statements,” including, without limitation,
statements regarding the potential benefits, clinical and
regulatory development and commercialization of soticlestat, the
potential value and benefits of the collaboration with Takeda, the
anticipated reporting schedule of clinical data, 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.
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Takeda Media: Japanese Media Kazumi Kobayashi
kazumi.kobayashi@takeda.com +81 (0) 3-3278-2095
Media outside Japan Chris Stamm chris.stamm@takeda.com +1 (617)
347-7726
Ovid Investors and Media: Ovid Therapeutics Inc. Investor
Relations & Public Relations irpr@ovidrx.com
Or
Ovid Investors: Steve Klass Burns McClellan, Inc. +1
(212) 213-0006 sklass@burnsmc.com
Ovid Media: Dan Budwick 1AB dan@abmedia.com
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