GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the science, development, and
commercialization of cannabinoid prescription medicines, along with
U.S. subsidiary Greenwich Biosciences, announced today that JAMA
Neurology has published results from the second positive Phase 3
trial (GWPCARE2) of EPIDIOLEX® (cannabidiol) oral solution CV in
children with seizures associated with Dravet syndrome. The article
has been published online and will be included in the May 2020
print issue of the journal. EPIDIOLEX, a pharmaceutical formulation
of highly purified cannabidiol (CBD), is the first prescription,
plant-derived cannabis-based medicine approved by the U.S. Food and
Drug Administration (FDA) for the treatment of seizures associated
with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients
two years of age or older.
In the study, two doses of EPIDIOLEX, 10 and 20
mg/kg/day, significantly reduced convulsive seizure frequency
compared to placebo in children two to 18 years of age with highly
treatment-resistant Dravet syndrome, meeting the study’s primary
endpoint. The primary endpoint outcomes for the 10 and 20 mg/kg/day
arms were similar, with seizure reductions of 49% and 46% from
baseline, respectively, vs 27% for placebo (10 mg/kg/day, p=0.0095
and 20 mg/kg/day, p=0.0299).
“Dravet syndrome is one of the most
difficult-to-treat forms of epilepsy and patients are highly
individualized in their symptoms and dosing needs,” said Ian
Miller, M.D., Chief of Neurology at Nicklaus Children's Hospital in
Miami, FL and lead author. “The data published by JAMA Neurology
show that EPIDIOLEX 10 and 20 mg/kg/day were both efficacious and
significantly reduced convulsive seizures. Drug-resistant seizures
are common with Dravet syndrome and it is valuable to have a range
of approved doses that offer physicians the flexibility to adjust
treatment to a patient’s specific needs.”
Results from key secondary endpoints also showed:
- Significant reductions in total
seizure frequency from baseline: 56% for 10 mg/kg/day and 47% for
20 mg/kg/day vs 30% for placebo (p=0.0003 and p=0.0255,
respectively).
- Significantly more patients taking
EPIDIOLEX (44% on 10 mg/kg/day and 49% on 20 mg/kg/day) achieved a
50 percent or greater reduction in convulsive seizures from
baseline during the treatment period compared to placebo (26%;
p=0.0332 and p=0.0069, respectively).
- Compared with placebo, caregivers
of patients treated with EPIDIOLEX were significantly more likely
to report an improvement in overall condition as measured by the
Caregiver Global Impression of Change (CGIC) scale at last visit
(10 mg/kg/day, p=0.0009 and 20 mg/kg/day, p=0.0279).
The most common adverse reactions in the study
(occurring in at least 10% of patients in any group) included
decreased appetite, diarrhea, somnolence, pyrexia, and fatigue.
Elevated liver transaminases occurred more frequently on 20
mg/kg/day than 10 mg/kg/day cannabidiol, with all affected patients
on concomitant valproate.
“EPIDIOLEX continues to represent an important
advancement in the treatment of difficult-to-treat pediatric-onset
epilepsies such as Dravet syndrome where there are few FDA-approved
therapies,” said Justin Gover, GW CEO. “We are pleased that the
full results of our GWPCARE2 study in Dravet syndrome are now
available to the greater neurology community. The continued
publication of our data is a testament to our groundbreaking
research in the field of cannabinoids, which we plan to continue to
advance in an effort to bring more novel treatments to patients in
need.”
Study Overview
The pivotal Phase 3 study of EPIDIOLEX –
GWPCARE2 – was a randomized, double-blind placebo-controlled trial
of patients aged 2-18 years with a confirmed diagnosis of
drug-resistant Dravet syndrome currently uncontrolled on one or
more concomitant anti-epileptic drugs (AEDs). The trial randomized
199 patients into three arms, where EPIDIOLEX 10 mg/kg/day (n=67),
EPIDIOLEX 20 mg/kg/day (n=67), or placebo (n=65) was added to
current AED treatment. On average, patients were taking three AEDs,
having previously tried and discontinued on average, four other
AEDs. The average age of trial participants was 9 years. The median
baseline convulsive seizure frequency per month was 12 and the
median baseline total seizure frequency per month was 35.
“When scientific research is validated by
esteemed journals like JAMA Neurology, it’s a win for every member
of the Dravet community seeking more information and a greater
understanding of treatments for their condition,” said Mary Anne
Meskis, Executive Director of the Dravet Syndrome Foundation.
“Patients and their families are in need of treatment options that
work for this devastating illness and it’s exciting to see further
proof that EPIDIOLEX has the potential to make a meaningful
difference in patients’ lives.”
Results from the first positive Phase 3 pivotal
trial of EPIDIOLEX in patients with Dravet syndrome were published
in The New England Journal of Medicine.1 The EPIDIOLEX clinical
program now includes five positive randomized, controlled Phase 3
clinical trials in Lennox-Gastaut Syndrome, Dravet syndrome and
tuberous sclerosis complex.
About Dravet SyndromeDravet
syndrome is a rare, severe, lifelong form of epilepsy that
typically begins in the first year of life with frequent and/or
prolonged seizures.2 Previously known as severe myoclonic epilepsy
in infancy (SMEI), it affects between 1 in 20,000 to 1 in 40,000
people.3,4 About 80 percent of people with this syndrome have a
gene mutation that causes problems in the way the brain works.2
Children with Dravet syndrome can develop many
different seizure types and approximately 15 percent die within 10
years of diagnosis due to issues such as SUDEP (sudden unexpected
death in epilepsy), prolonged seizures (status epilepticus),
seizure-related accidents such as drowning, or
infections.2,5 Additionally, the majority will develop
moderate to severe intellectual and developmental disabilities6 and
require lifelong supervision and care.2
About EPIDIOLEX® (cannabidiol) oral solution,
CV
EPIDIOLEX® (cannabidiol) oral solution CV, a
pharmaceutical formulation of highly purified cannabidiol (CBD), is
the first in a novel class of anti-epileptic medications and the
first prescription, plant-derived cannabis-based medicine approved
by the U.S. Food and Drug Administration (FDA). In the U.S.,
EPIDIOLEX is indicated for the treatment of seizures associated
with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients
two years of age or older. A supplemental New Drug Application
(sNDA) has been submitted to the FDA for the treatment of seizures
associated with tuberous sclerosis complex (TSC). EPIDIOLEX has
received approval in the European Union under the tradename
EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat
seizures associated with LGS and Dravet syndrome.
EPIDIOLEX/EPIDYOLEX has received Orphan Drug Designation from the
FDA and the EMA for the treatment of seizures associated with
Dravet syndrome, LGS and TSC, each of which are severe
childhood-onset, drug-resistant syndromes.
Important Safety InformationImportant safety
information for EPIDIOLEX is available at EPIDIOLEX.com.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform in a broad range of disease areas. The Company’s
lead product, EPIDIOLEX® (cannabidiol) oral solution, CV, is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older. This product has received approval in the
European Union under the tradename EPIDYOLEX®. The Company has
submitted a supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) seeking to expand the indication
for EPIDIOLEX to include seizures associated with tuberous
sclerosis complex (TSC), for which it has reported positive Phase 3
data, and is carrying out a Phase 3 trial in Rett syndrome. The
Company has a deep pipeline of additional cannabinoid product
candidates, in particular nabiximols, for which the Company is
advancing multiple late-stage clinical programs in order to seek
FDA approval in the treatment of spasticity associated with
multiple sclerosis and spinal cord injury, as well as for the
treatment of PTSD. The Company has additional cannabinoid product
candidates in Phase 2 trials for autism and schizophrenia. For
further information, please visit www.gwpharm.com.
Forward-looking statements This
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding financial performance, the timing of clinical trials, the
timing and outcomes of regulatory or intellectual property
decisions, the relevance of GW products commercially available and
in development, the clinical benefits
of EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral
solution CV and Sativex® (nabiximols), and the safety
profile and commercial potential of both medicines. Forward-looking
statements involve risks and uncertainties. Actual events could
differ materially from those projected herein and depend on a
number of factors, including (inter alia), the success of GW’s
research strategies, the applicability of the discoveries made
therein, the successful and timely completion and uncertainties
related to the regulatory process, and the acceptance of
EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer
and medical professionals. A further list and description of risks
and uncertainties associated with an investment in GW can be found
in GW’s filings with the U.S. Securities and Exchange Commission.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. GW undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise.
Enquiries:
GW Pharmaceuticals plc |
Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
|
|
U.S. Media Enquiries: |
Sam Brown Inc. Healthcare Communications |
Christy Curran |
615 414 8668 |
Mike Beyer |
312 961 2502 |
_____________________
1Devinsky O, Cross JH, Laux L, et al. Trial of
cannabidiol for drug-resistant seizures in the Dravet syndrome. N
Engl J Med 2017; 376;2011-20.2Dravet Syndrome Foundation. What is
Dravet Syndrome? Available at
https://www.dravetfoundation.org/what-is-dravet-syndrome/. Accessed
May 15, 2018.3Dravet C, The core Dravet syndrome phenotype.
Epilepsia. 2011;52(Suppl. 2):3-9.4Dravet C, Bureau M, Oguni H,
Cokar O, Guerrini R. Dravet syndrome (severe myoclonic epilepsy in
infancy). In: Bureau M, Genton P, Dravet C, et al., eds. Epileptic
Syndromes in Infancy, Childhood and Adolescence. Montrouge, France:
John Libbey Eurotext Ltd.; 2012:112-156.5Cooper MS, Mcintosh A,
Crompton DE, et al. Mortality in Dravet syndrome. Epilepsy Res.
2016;128:43-47.6Scheffer IE, Diagnosis and long-term course of
Dravet syndrome. European Journal of Paediatric Neurology.
2012;04.007.
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Jun 2024 to Jul 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Jul 2023 to Jul 2024