GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Highlight New Epidiolex® (cannabidiol) Data Released by the...
April 18 2017 - 4:26PM
GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW,” “the Company” or
“the Group”), a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its
proprietary cannabinoid product platform, noted that the American
Academy of Neurology (AAN) issued a press release today announcing
positive results from a second Phase 3 study (GWPCARE3) of
Epidiolex® (cannabidiol or CBD) in children and adults with
Lennox-Gastaut syndrome (LGS). The data will be presented at the
upcoming meeting of the American Academy of Neurology (AAN) in
Boston, MA.
In the GWPCARE3 study, adding Epidiolex to
patients’ current treatment significantly reduced the frequency of
drop seizures at both the 10 mg/kg/day and 20mg/kg/day doses.
During the 14-week treatment period, patients taking both doses of
Epidiolex saw a significantly greater median reduction in monthly
drop seizures (37 percent and 42 percent, respectively) compared
with a 17 percent reduction for placebo (p=0.0016 and p=0.0047,
respectively). New data from key secondary endpoints also showed
that a significant number of patients receiving Epidiolex 10
mg/kg/day (36 percent) and Epidiolex 20 mg/kg/day (40 percent)
experienced a 50 percent or greater reduction in monthly drop
seizures compared with those taking placebo (15 percent, p=0.0030
and p=0.0006, respectively). In addition, significantly more
patients/caregivers reported an improvement in overall condition
with Epidiolex 10mg/kg/day (66 percent) and Epidiolex 20mg/kg/day
(57 percent) compared to 44 percent for placebo (p<0.05 for both
comparisons) based on the Subject/Caregiver Global Impression of
Change (S/CGIC) questionnaire.
"Lennox-Gastaut syndrome is one of the most
challenging types of epilepsy to treat. Results from this
large, placebo-controlled study demonstrate that Epidiolex provides
clinically meaningful reductions in seizure frequency together with
an acceptable safety and tolerability profile," said study
investigator Anup Patel, M.D., of Nationwide Children’s Hospital
and The Ohio State University College of Medicine. “I believe
Epidiolex has the potential to change the treatment of LGS and I am
excited at the future prospect of prescribing an appropriately
standardized and tested pharmaceutical formulation of
cannabidiol."
Epidiolex was generally well tolerated in the
trial. The pattern of adverse events was consistent with that
reported in previous Phase 3 studies. One patient on 10mg/kg
Epidiolex discontinued treatment due to an adverse event compared
with six patients on 20mg/kg and one patient on
placebo. Adverse events (AEs) occurred in 94 percent of
patients taking Epidiolex 20mg/kg, 84 percent of patients taking
Epidiolex 10mg/kg, and 72 percent of placebo patients. Most were
mild or moderate; the two most common (greater than 10 percent)
were sleepiness and decreased appetite.
"We are pleased that AAN has chosen to highlight
data from our Phase 3 epilepsy program at this prestigious meeting
of the broader neurology community. New results from our largest
and most recently completed LGS study offer a first look at the
significant efficacy of two different doses of Epidiolex added to
existing anti-epileptic drug treatment over placebo,” said Justin
Gover, GW's Chief Executive Officer. “This latest data from our
Phase 3 program reinforces the potential of Epidiolex to become an
important new medicine for patients who suffer from LGS and our
planned NDA submission remains on track for the middle of this
year.”
Additional data will be presented in a poster at
the AAN Annual Meeting on April 25, 2017 at 6.06pm EDT, at which
time GW will make an additional disclosure.
The full text of the AAN announcement is
available at: https://www.aan.com/pressroom.
About Lennox-Gastaut
Syndrome
The peak onset of LGS typically occurs between
ages of three to five years and can be caused by a number of
conditions, including brain malformations, severe head injuries,
central nervous system infections, and inherited degenerative or
metabolic conditions. In up to 30 percent of patients, no cause can
be found. Patients with LGS commonly have multiple seizure types
including drop, convulsive and non-convulsive seizures, which
frequently lead to falls and injuries. Drug resistance is one of
the main features of LGS. Most children with LGS experience
intellectual disability and behavioral disturbances. It is
estimated that there are approximately 14,000-18,500 patients with
LGS in the United States and 23,000-31,000 patients with
LGS in Europe.
About Epidiolex
Epidiolex, GW's lead cannabinoid product
candidate, is a liquid formulation of plant-derived cannabidiol
(CBD), which is in development for the treatment of a number of
rare childhood-onset epilepsy disorders. GW has conducted extensive
pre-clinical research of CBD in epilepsy since 2007. This research
has shown that CBD has significant anti-epileptiform and
anticonvulsant activity using a variety of in-vitro and in-vivo
models and efficacy in reducing seizures in acute animal models of
epilepsy with significantly fewer side effects than existing
anti-epileptic drugs. To date, GW has received Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
Epidiolex for the treatment of Dravet syndrome, Lennox-Gastaut
syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile
Spasms (IS), each of which are severe infantile-onset,
drug-resistant epilepsy syndromes. Additionally, GW has received
Fast Track Designation from the FDA for the treatment of
Dravet syndrome and Orphan Designation from the European Medicines
Agency, or EMA, for Epidiolex for the treatment of Dravet syndrome
and LGS. GW is currently evaluating additional clinical development
programs in other orphan seizure disorders.
About GW Pharmaceuticals
plc
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. GW is advancing an
orphan drug program in the field of childhood-onset epilepsy with a
focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical
development for the treatment of Dravet syndrome, Lennox-Gastaut
syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW
commercialized the world’s first plant-derived cannabinoid
prescription drug, Sativex® (nabiximols), which is approved for the
treatment of spasticity due to multiple sclerosis in 31 countries
outside the United States. The Company has a deep pipeline of
additional cannabinoid product candidates which includes compounds
in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. In
the United States, GW operates through its subsidiary Greenwich
Biosciences, Inc. 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® and the safety profile and commercial potential of
Epidiolex. 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 of uncertainties related to the regulatory
process, and the acceptance of Epidiolex 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, including the most recent Form 20-F filed on 5 December
2016. 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: |
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GW Pharmaceuticals plc |
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Stephen Schultz, VP Investor Relations |
401
500 6570 |
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U.S. Media Enquiries: |
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Sam Brown Inc. Healthcare Communications |
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Christy Curran |
615 414 8668 |
Mike
Beyer |
312 961 2502 |
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