GW Pharmaceuticals Announces Preliminary Results of Phase 2a Study for its Pipeline Compound GWP42006
February 21 2018 - 04:01PM
-Study did not meet its primary endpoint-
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, today announced that a
Phase 2a proof of concept study of a pipeline compound GWP42006 in
adult patients with focal seizures did not meet its primary
endpoint. GWP42006 is also being developed within the field of
autism spectrum disorders (ASD) which will represent an increased
therapeutic focus for ongoing development of this pipeline
compound.
GWP42006 trial in focal
seizures
The Phase 2a placebo-controlled study evaluated
the efficacy and safety of GWP42006, which features cannabidivarin
(CBDV) as the primary cannabinoid molecule, as add-on therapy in
162 adult patients with inadequately controlled focal seizures. The
trial was conducted outside the United States, primarily in Eastern
Europe. In the trial’s preliminary top-line results, both active
and placebo arms showed similar reductions in focal seizures of
approximately 40 percent. The extent of this placebo response is
substantially greater than that seen in published studies of other
treatments in similar patient populations and the Company is now
working to understand the potential reasons for this result. In the
trial, GWP42006 was generally well tolerated. More patients in the
active group (73 percent) experienced treatment emergent adverse
events compared to the placebo group (48 percent). A majority of
the GWP42006 patients experienced adverse events of mild or
moderate severity. The incidence of serious adverse events was low
(3.7 percent on active compared to 1.2 percent on placebo).
GWP42006 has shown anti-epileptic properties
across a range of in vitro and in vivo models of epilepsy. GW will
continue to explore potential development opportunities for this
compound in the field of epilepsy.
GWP42006 progress in Autism Spectrum
Disorders
In parallel with this study, GW has been
evaluating GWP42006 in both general and syndromic pre-clinical
models of ASD yielding promising signals on cognitive and social
endpoints as well as repetitive behavior. These include both
genetically determined abnormalities of neurobehavioral, and
chemically-induced models, and include Rett syndrome and Fragile X
among others. GW will continue to advance various clinical
initiatives within the field of ASD, including a physician-led
expanded access IND in 10 patients with autism as well as both
open-label and Phase 2 placebo-controlled trials in Rett syndrome,
a condition for which GWP42006 has received Orphan Drug Designation
from the FDA. Open label data from the expanded access IND are
expected later in 2018.
“GW’s R&D focus has evolved in the last few
years towards pediatric neurology where we have generated
significant positive clinical data. Whilst the results of
this adult focal seizure study for GWP42006 are disappointing, we
remain committed to advancing this pipeline compound to address
unmet needs in the field of autism spectrum disorders, in which a
promising body of pre-clinical data has already been generated, as
well as continuing to explore the product’s potential within the
field of epilepsy,” said Justin Gover, GW’s Chief Executive
Officer. “The company’s top priority in 2018 remains Epidiolex, for
which we have generated compelling positive data in three Phase 3
trials, and which is currently under regulatory review in the U.S.
and Europe. We are very excited at the prospect of launching this
potential breakthrough treatment later this year in the U.S.,
whilst continuing to progress our broad and innovative cannabinoid
pipeline.”
About GW Pharmaceuticals plc and
Greenwich Biosciences
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, along with its U.S.
subsidiary Greenwich Biosciences, is advancing an orphan drug
program in the field of childhood-onset epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted regulatory
applications in the U.S. and Europe for the adjunctive treatment of
Lennox-Gastaut syndrome and Dravet syndrome. The Company continues
to evaluate Epidiolex in additional rare epilepsy conditions and
currently has ongoing clinical trials in 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 numerous countries outside the United States and for
which the company is now planning a US Phase 3 trial. The Company
has a deep pipeline of additional cannabinoid product candidates
which includes compounds in Phase 1 and 2 trials for epilepsy,
gliobastoma, 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
GWP42006 and the safety profile and commercial potential of
GWP42006. 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 Sativex, 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 4 December 2017. 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 |
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Stephen Schultz, VP Investor Relations (U.S.) |
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U.S. Media
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Sam Brown Inc.
Healthcare Communications |
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Christy Curran |
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615 414 8668 |
Mike
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