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RNS Number : 8260K
GW Pharmaceuticals PLC
26 September 2016
GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal
Trial for Epidiolex(R) (cannabidiol) in the Treatment of
Lennox-Gastaut Syndrome
- Primary endpoint achieved in both Epidiolex doses with high
statistical significance compared to placebo -
- Today's data represents the third positive Phase 3 pivotal
trial for Epidiolex reported in 2016 -
- Data reinforce the potential of Epidiolex to be an important
new medicine for patients who suffer from this treatment-resistant
childhood-onset epilepsy -
- Company to hold investor conference call today at 8:00 a.m.
EDT/13:00 BST -
London, UK; 26 Sept 2016: GW Pharmaceuticals plc (Nasdaq: GWPH,
AIM: "GWP," "GW," "the Company" or "the Group"), a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform, announces positive results of the second
randomized, double-blind, placebo-controlled Phase 3 clinical trial
of its investigational medicine Epidiolex(R) (cannabidiol or CBD)
for the treatment of seizures associated with Lennox-Gastaut
syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
In this trial, Epidiolex, when added to the patient's current
treatment, achieved the primary endpoint for both dose levels with
high statistical significance. During the treatment period,
patients taking Epidiolex 20mg/kg/day achieved a median reduction
in monthly drop seizures of 42 percent compared with a reduction of
17 percent in patients taking placebo (p=0.0047), and patients
taking Epidiolex 10mg/kg/day achieved a median reduction in monthly
drop seizures of 37 percent compared with a reduction of 17 percent
in patients taking placebo (p=0.0016).
This trial follows the announcement in June 2016 of positive
results in the first pivotal Phase 3 trial of Epidiolex for the
treatment of seizures associated with LGS, and the March 2016
announcement of positive results in the treatment of seizures
associated with Dravet syndrome. GW expects to submit a New Drug
Application (NDA) to the U.S. Food & Drug Administration (FDA)
in the first half of 2017.
"The positive outcome in this second trial of Epidiolex in
patients with Lennox-Gastaut syndrome demonstrates the
effectiveness of this product in this particularly difficult to
treat, childhood-onset epilepsy," stated Orrin Devinsky, M.D., of
New York University Langone Medical Center's Comprehensive Epilepsy
Center and principal investigator in the trial. "The data from the
Epidiolex Dravet and LGS studies offers the prospect of an
FDA-approved CBD medicine that shows both clinically meaningful
seizure reduction and a consistent safety and tolerability profile.
I believe Epidiolex has the potential to become an important new
option within the field of treatment-resistant epilepsy."
"Today brings great news for the Lennox-Gastaut Syndrome
community," said Christina SanInocencio, Executive Director of the
Lennox-Gastaut Syndrome Foundation. "The announcement of a second
set of positive results with Epidiolex is exciting as they offer
much needed hope for patients and their families living with this
debilitating condition where new treatment options are desperately
needed."
"The Epilepsy Foundation is thrilled to learn about the recent
preliminary results for an innovative new therapy from GW for LGS.
LGS in so many cases is extremely difficult to treat, and is an
incredible challenge for children and families. We feel a
tremendous sense of urgency to stop seizures, and believe that the
pursuit of new therapies offers hope to individuals who have no
currently available therapy to effectively stop their seizures. The
Epilepsy Foundation will continue to be a champion for GW's efforts
to pursue this innovative new therapy as studies progress. We thank
GW and all our partners who invest in a better tomorrow for people
with epilepsy," stated Philip Gattone, President and Chief
Executive Officer of the Epilepsy Foundation.
"We are very pleased to report this second positive Phase 3
trial in seizures associated with Lennox-Gastaut Syndrome. This is
the third positive Phase 3 trial for Epidiolex reported in 2016.
All three trials provide GW with robust evidence to support the
efficacy and safety of Epidiolex. This latest trial also shows that
Epidiolex likely has an effective dose range, allowing for dose
flexibility to address individual patient needs. These compelling
results make us more determined than ever to make this important
new medicine available to patients who suffer from these
treatment-resistant childhood-onset epilepsies," stated Justin
Gover, GW's Chief Executive Officer.
Trial Overview and Result
Patients aged 2-55 years with a confirmed diagnosis of
drug-resistant LGS currently uncontrolled on one or more
concomitant anti-epileptic drugs (AEDs) were eligible to
participate in this Phase 3, randomized, double-blind
placebo-controlled trial. The trial randomized 225 patients into
three arms, where Epidiolex 20mg/kg/day (n=76), Epidiolex
10mg/kg/day (n=73) or placebo (n=76) was added to current AED
treatment. On average, patients were taking approximately three
AEDs, having previously tried and discontinued an average of seven
other AEDs. The average age of trial participants was 16 years (30
percent were 18 years or older). The median drop seizure frequency
over the 4 week baseline period was 85.
The primary efficacy endpoint of this trial was a comparison
between Epidiolex and placebo in the percentage change in the
monthly frequency of drop seizures during the 14 week treatment
period (two week dose escalation period followed by 12 weeks of
maintenance) compared to the 4 week baseline period before
randomization. Drop seizures were defined as atonic, tonic or
tonic-clonic seizures involving the entire body, trunk or head that
led or could have led to a fall, injury, slumping in a chair or
hitting the patient's head on a surface.
During the treatment period, patients taking Epidiolex
20mg/kg/day achieved a median reduction in monthly drop seizures of
42 percent compared with a reduction of 17 percent in patients
taking placebo (p=0.0047), and patients taking Epidiolex
10mg/kg/day achieved a median reduction in monthly drop seizures of
37 percent compared with a reduction of 17 percent in patients
taking placebo (p=0.0016).
A series of sensitivity analyses of the primary endpoint for
both dose groups confirmed the robustness of these results. In both
dose groups, the difference between Epidiolex and placebo emerged
during the first month of treatment and was sustained during the
entire treatment period. Results from secondary efficacy endpoints
in both dose groups reinforced the overall effectiveness observed
with Epidiolex.
Epidiolex was generally well tolerated in this trial. The
pattern of adverse events was consistent with that reported in the
previous two 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.
Of the 84 percent of 10mg/kg patients who experienced an adverse
event, 89 percent of them deemed it to be mild or moderate. Of the
94 percent of 20mg/kg patients who experienced an adverse event, 88
percent of them reported it to be mild or moderate. 72 percent of
patients on placebo experienced an adverse event.
The most common adverse events (occurring in greater than 10
percent of Epidiolex-treated patients) in the 10mg/kg group were:
somnolence, decreased appetite, upper respiratory infection,
diarrhea, and status epilepticus. None of the cases of status
epilepticus in the 10mg/kg group was deemed treatment-related. The
most common adverse events (occurring in greater than 10 percent of
Epidiolex-treated patients) in the 20mg/kg group were: somnolence,
decreased appetite, diarrhea, upper respiratory infection, pyrexia,
vomiting, and nasopharyngitis.
Thirteen patients on Epidiolex 10mg/kg experienced a serious
adverse event (two of which were deemed treatment-related) compared
with thirteen patients on 20mg/kg (five of which were deemed
treatment-related) and eight patients on placebo (none of which
were deemed treatment-related).
There were no deaths in this trial.
Of the patients who completed this trial, 99 percent have opted
to continue into an open-label extension trial.
Further data will be presented in future publications and
medical meetings.
Epidiolex New Drug Application (NDA)
Following the success of the first Dravet syndrome Phase 3 trial
earlier this year, GW requested a pre-NDA meeting with the FDA to
discuss a proposed Dravet syndrome NDA. This meeting took place in
July 2016 and also included some discussion of data from the first
Phase 3 LGS trial. As a result of this constructive meeting, GW
believes the guidance received enables the Company's proposed
filing strategy to submit a single NDA that includes Phase 3 data
from one Dravet trial and two LGS trials, and which remains on
track for a submission in the first half of 2017. Subject to
satisfactory review, GW now anticipates a simultaneous decision on
both indications and does not expect to wait for results from the
second trial in Dravet syndrome prior to this submission.
In order to support GW's NDA, the Company expects to provide the
FDA with data from ten Phase 1 and Phase 2 studies, as well as
safety data in over 1,800 patients from both the expanded access
program and pivotal programs, including over 450 patients with one
year or more of Epidiolex continuous exposure. This data is in
addition to the pivotal efficacy data.
Epidiolex has Orphan Drug Designation from the FDA for the
treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex and
Infantile Spasms.
GW Clinical Trial Programs in Dravet Syndrome, Tuberous
Sclerosis Complex and Infantile Spasms
In March 2016, GW announced positive results of the first
pivotal Phase 3 trial of Epidiolex in Dravet syndrome. GW continues
to enroll a second Phase 3 trial of Epidiolex in Dravet syndrome
and will report these results upon completion. GW has commenced a
Phase 3 trial of Epidiolex in Tuberous Sclerosis Complex and
expects to initiate a Phase 3 trial of Epidiolex in Infantile
Spasms in the fourth quarter of this year.
Investor Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast for
analysts and investors to discuss the results from this initial
Phase 3 trial today at 8:00 a.m. EDT /13:00 BST. To participate in
the conference call, please dial 877-407-8133 (toll free from the
U.S. and Canada), or 0800-756-3429 (toll free from the UK) or
201-689-8040 (international). Investors may also access a live
audio webcast of the call via the investor relations section of the
Company's website at http://www.gwpharm.com. A replay of the call
will also be available through the GW website shortly after the
call and will remain available for 90 days. Replay Numbers: (toll
free): 1-877-660-6853, (international): 1-201-612-7415. For both
dial-in numbers please use conference ID # 13646262.
About Lennox-Gastaut Syndrome
The peak onset of LGS typically occurs between ages of 3 to 5
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 non-convulsive,
convulsive and drop seizures, which frequently lead to falls and
injuries. Drug resistance is one of the main features of LGS. Most
children with LGS experience some degree of impaired intellectual
functioning, as well as developmental delays and behavioral
disturbances. Latest estimates are that there are more than 30,000
patients with LGS in the United States.
About Epidiolex
Epidiolex, GW's lead cannabinoid product candidate, is an oral
pharmaceutical formulation of 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 reduced seizures in various acute
animal models of epilepsy. To date, GW has received Orphan Drug
Designation from the FDA for Epidiolex for the treatment of Dravet
syndrome, LGS, Tuberous Sclerosis Complex and Infantile Spasms.
Additionally, GW has received Fast Track Designation from the FDA
and Orphan Designation from the European Medicines Agency for
Epidiolex for the treatment of Dravet syndrome. 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(R)
(cannabidiol), which is in Phase 3 clinical development for the
treatment of Dravet syndrome, LGS and Tuberous Sclerosis Complex.
GW successfully developed the world's first plant-derived
cannabinoid prescription drug, Sativex(R), which is approved for
the treatment of spasticity due to multiple sclerosis in 28
countries outside the United States. GW has a deep pipeline of
additional cannabinoid product candidates which includes compounds
in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For
further information, please visit www.gwpharm.com.
Forward-looking statements
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
statements regarding the therapeutic benefit, safety profile and
commercial value of the Company's investigational drug Epidiolex,
the development and commercialization of Epidiolex, plans and
objectives for product development, plans and objectives for
present and future clinical trials and results of such trials,
plans and objectives for regulatory submissions and approvals.
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 the 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 Sativex, Epidiolex, if approved, and other products which we may
commercialize by consumer and medical professionals. A further list
and description of risks, uncertainties and other risks 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.
Contacts: GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations 401 500 6570 / 917 280 2424
FTI Consulting (UK Media)
Ben Atwell / Simon Conway +44 20 3727 1000
FleishmanHillard (U.S. Media)
Paddi Hurley / Adam Silverstein 212 453 2382 / 212 453 2493
Peel Hunt LLP (UK NOMAD)
James Steel +44 20 7418 8900
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCPGUGWBUPQGUQ
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