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RNS Number : 4278C
GW Pharmaceuticals PLC
17 March 2014
GW Pharmaceuticals Provides Update on Cannabinoid Pipeline
- CBDV Phase 1 Safety Results and Patent Allowance -
- Type 2 Diabetes Phase 2b Trial Commences -
- Schizophrenia Phase 2 Trial Commences -
London, UK; 17 March 2014: 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, today provided an update on the Company's cannabinoid
pipeline.
"While much of the recent attention regarding GW has been
associated with our childhood epilepsy and cancer pain development
programs, we continue to make great progress with other pipeline
programs, further demonstrating the breadth of our proprietary
cannabinoid product development platform to yield interesting and
therapeutically beneficial product candidates." stated Dr. Stephen
Wright, GW's Director of Research and Development. "As GW continues
to progress its clinical work with cannabinoids, our pipeline has
the potential to yield, as it did with Epidiolex, a flow of
exciting new product candidates in a wide variety of therapeutic
areas."
GWP42006 (CBDV) for epilepsy
GW has completed a Phase 1 clinical trial of GWP42006 to treat
epilepsy. GWP42006 is a product which features the non-psychoactive
cannabinoid cannabidivarin (CBDV) extracted from the cannabis
plant. This Phase 1 single ascending and multiple dose
pharmacokinetic and safety study in 66 healthy subjects
demonstrated no safety or toxicity signals. In this study, subjects
were dose titrated to investigate the maximum tolerated dose and to
determine what, if any, side effects resulted. CBDV was well
tolerated even at the highest tested dose and no significant side
effects were observed. There were no serious or severe adverse
events, nor any withdrawals due to adverse events, and all mild
adverse events resolved on treatment.
CBDV has shown the ability to treat seizures in pre-clinical
models of epilepsy with significantly fewer side effects than
currently approved anti-epileptic drugs(1) . CBDV also appears to
employ a different mechanism of action to currently available
anti-epileptic treatments. GW expects to commence a Phase 2 study
of CBDV in patients with epilepsy later in 2014, using the doses
identified as appropriate in this Phase 1 study.
GW also announced that the Intellectual Property Office in the
United Kingdom has granted a patent for the use of CBDV in the
treatment of epilepsy, patent number GB2479153B. The subject patent
covers the use of CBDV alone or in combination with standard
anti-epileptic drugs or in combination with other cannabinoids, and
provides an exclusivity period until 30 March 2030. This same
patent is currently in prosecution with the United States Patent
and Trademark Office.
CBDV is one of two product candidates being investigated by GW
in the field of epilepsy. The other candidate, Epidiolex, contains
plant-derived cannabidiol (CBD) as its active ingredient. Epidiolex
has received orphan drug designation from the FDA in the treatment
of Dravet syndrome and Lennox-Gastaut syndrome, two infantile onset
drug-resistant epilepsy syndromes. The FDA has granted expanded
access INDs to several independent investigators in the U.S. to
allow treatment of pediatric epilepsy patients with Epidiolex.
GWP42004 for Type 2 diabetes
GW has commenced a 12-week randomized, double blind, placebo
controlled Phase 2b study of GWP42004 to treat Type 2 diabetes.
GWP42004 is an orally administered product which features
plant-derived tetrahydrocannabivarin (THCV) as its active
ingredient. THCV is distinct from THC and does not share its
intoxicating psychoactive effects. The primary objective of this
study is to compare the change in glycaemic control in participants
with Type 2 diabetes when treated with one of three doses of
GWP42004 or placebo as add-on therapy to metformin with the primary
endpoint being change from baseline to the end of treatment in mean
glycosylated haemoglobin A1c (HbA1c) level. The safety and
tolerability of GWP42004 compared with placebo will also be
assessed. This study is expected to enroll approximately 200
patients with an estimated completion date of the second half of
2015.
This study follows positive findings reported in November 2012
from a Phase 2a exploratory study, showing evidence of
anti-diabetic effects and supporting advancement of GWP42004 into
further clinical development. The Phase 2a trial enrolled a total
of 62 Type 2 diabetes patients and showed that GWP42004 produced a
variety of desirable anti-diabetic effects including reduced
fasting plasma glucose levels, an increase in fasting insulin,
improved pancreatic beta-cell function, increased serum
adiponectin, reduced systolic blood pressure, and reduced serum
IL-6 levels. Several of these findings are consistent with
pre-clinical data suggesting that GWP42004 protects the
insulin-producing cells of the pancreatic islets, a highly
desirable feature of a new anti-diabetic medicine, increases
insulin sensitivity, and reduces fasting plasma glucose levels.
GW believes that if the Phase 2b study confirms the Phase 2a
findings, GWP42004 would have the potential to offer a novel
orally-administered treatment option within one of the largest
therapeutic areas where a serious unmet medical need still
exists.
GWP42003 for schizophrenia
GW has commenced a Phase 2a trial using GWP42003 to treat
schizophrenia. GWP42003 featured purified CBD as its active
ingredient. The primary objective of this study is to compare the
change in symptom severity in patients with schizophrenia or
related psychotic disorder when treated with GWP42003 or placebo,
added to first-line anti-psychotic therapy over a period of six
weeks as change from baseline to the end of treatment using the
Positive and Negative Symptom Scale (PANSS)(2) total score.
Secondary objectives are to evaluate the effect of GWP42003 on
quality of life and cognition and to assess the safety and
tolerability of GWP42003. This study is expected to enroll
approximately 80 patients with an estimated completion date of the
second half of 2015.
GWP42003 has shown notable anti-psychotic effects in accepted
pre-clinical models of schizophrenia and importantly has also
demonstrated the ability to reduce the characteristic movement
disorders induced by currently available anti-psychotic agents. The
mechanism of GWP42003 does not appear to rely on the D2 receptor
augmentation of standard antipsychotics and therefore has the
potential to offer a novel treatment option in this therapeutic
area.
Rest of Pipeline
In addition to the pipeline programs highlighted above, GW
continues to advance other programs, including:
- Sativex in Phase 3 clinical development for cancer pain.
Initial top line Phase 3 data expected towards the end of 2014
- Sativex in Phase 3 clinical development for MS spasticity. US
Phase 3 trial expected to commence in second half of 2014
- GWP42003 extract in Phase 2 clinical development for
ulcerative colitis. Phase 2 data expected mid-2014
- GWP42002:GWP42003 in Phase 1b/2a clinical development for recurrent glioblastoma multiforme
1: Hill et al, British Journal of Pharmacology, September
2012;
2: The PANSS is a medical scale completed by a trained rater at
site and is used for measuring symptom severity of patients with
schizophrenia or related psychotic disorder. It is a 30 item rating
instrument that assesses the positive and negative symptoms of
schizophrenia as well as symptoms of general psychopathology. A
PANSS total score is derived from the sum of the 30 items and the
PANSS items are also grouped into three subscales: Positive ('P'),
Negative ('N'), and General ('G'). Individual items are rated on a
seven point scale, where 1 = absent and 7 = extreme. A decrease in
total score indicates an improvement in condition.
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 commercialized the world's first plant-derived
cannabinoid prescription drug, Sativex(R), which is approved for
the treatment of spasticity due to multiple sclerosis in 25
countries. Sativex is also in Phase 3 clinical development as a
potential treatment of pain in people with advanced cancer. This
Phase 3 program is intended to support the submission of a New Drug
Application for Sativex in cancer pain with the U.S. Food and Drug
Administration and in other markets around the world. GW has a deep
pipeline of additional cannabinoid product candidates, including
Epidiolex which has received Orphan Drug Designation from the FDA
for the treatment of Dravet and Lennox-Gastaut syndromes, severe,
drug-resistant epilepsy syndromes. GW's product pipeline also
includes compounds in Phase 1 and 2 clinical development for
glioma, ulcerative colitis, type--2 diabetes, and schizophrenia.
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 and commercial value of the
company's compounds, the development and commercialization of
Epidiolex(R), 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 approval.
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(R), Epidiolex(R), and other products 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.
Enquiries:
GW Pharmaceuticals plc (Today) + 44 20 3727 1000
Justin Gover, Chief Executive Officer (Thereafter) + 44 1980
557000
Stephen Schultz, VP Investor Relations
(US) 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen
(UK) + 44 20 3727 1000
Robert Stanislaro (US) 212 850 5657
Trout Group, LLC (US investor relations)
Todd James / Chad Rubin 646 378 2900
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
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