GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), a world leader in the science, development, and
commercialization of cannabinoid prescription medicines, along with
U.S. subsidiary Greenwich Biosciences, today announced that the
Company will present positive data from two analyses of Phase 3
clinical trials of nabiximols in persons with multiple sclerosis
(MS)-associated spasticity. Results showed that nabiximols was well
tolerated and provided continued reductions in spasticity for those
who remained on therapy while having no notable negative effects on
cognition, depression, or suicidality.
The data are planned for presentation at
MSVirtual2020, the 8th joint meeting of the Americas Committee for
Treatment and Research in Multiple Sclerosis (ACTRIMS) and the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) on September 11 at 8:00 AM EST. Nabiximols, known as
Sativex® outside of the U.S., is preparing to enter pivotal Phase 3
development in the U.S.
“We are pleased to share these study results,
which highlight additional clinical evidence of the favorable
safety profile and efficacy of nabiximols, with the medical
community at MSVirtual2020,” said Justin Gover, GW’s Chief
Executive Officer. “Nabiximols has the potential to offer people
with MS-related spasticity the first rigorously tested and
FDA-regulated cannabis medicine for the condition, which remains a
significant unmet therapeutic need in the U.S., and we look forward
to initiating our Phase 3 development program this year in pursuit
of that goal.”
The first presentation (P1109) includes results
from a post-hoc analysis of a Phase 3 clinical trial (GWSP0604)
conducted in two phases (A & B) to assess the favorable safety
profile and potential clinical efficacy of nabiximols in persons
with MS-associated spasticity. Phase A of the analysis (4 weeks)
evaluated the safety profile of nabiximols in responders vs
nonresponders; all participants received nabiximols in this
single-blind phase and 266 were labeled responders to treatment
with nabiximols out of 572 enrolled. Results from Phase A showed
that fewer responders reported an adverse event (AE) compared to
those who did not respond to treatment (40 percent vs. 53 percent).
AEs were similar between the groups, except dizziness, which
occurred more frequently in nonresponders vs responders (18 percent
vs 10 percent). At the end of Phase A, mean percent decrease in
spasticity numeric rating scale (NRS) was 44 percent for responders
vs 3 percent for nonresponders.
In Phase B, 241 of the 266 responders from Phase
A were randomized to nabiximols (n=124) or placebo (n=117) to
evaluate the potential clinical efficacy of nabiximols vs placebo
(12 weeks). At the end of Phase B, those receiving nabiximols
experienced a significantly greater mean percent decrease in
spasticity numeric rating scale (NRS) from Phase A baseline
compared to placebo (46 percent vs 34 percent; P=0.011) as well as
a significantly greater mean percent decrease in spasm frequency
(44 percent for nabiximols vs 24 percent for placebo; P=0.006).
More caregivers of participants on nabiximols also reported an
improvement from Phase A baseline on the Caregiver Global
Impression of Change (CGIC) scale (68 percent for nabiximols vs 43
percent for placebo). During Phase B, 53 percent of participants on
nabiximols reported one or more new AEs vs 49 percent on
placebo.
Overall results showed that nabiximols was well
tolerated and provided continued benefit to individuals who
remained on therapy.
“This analysis further clarifies the potential
clinical efficacy and favorable safety profile of nabiximols for
the treatment of MS-associated spasticity, where there has been
little therapeutic innovation in decades in the United States,”
said Dr. Aliza Ben-Zacharia, Multiple Sclerosis
Consultant/Researcher, Assistant Professor Mount Sinai Phillips
School of Nursing and Assistant Professor at Hunter College.
“Advancing the clinical development of nabiximols in the U.S. may
provide a viable and clinically-proven treatment option for people
living with MS and dealing with the challenges of
spasticity.”
The second virtual presentation (P1094) will
share results of an assessment of the impact of nabiximols on other
outcomes, such as cognition, depressive symptoms, and suicidality
in persons with MS-associated spasticity. The analysis used data
from two placebo-controlled, randomized trials: GWSP0604
(referenced above) (12 weeks) and GWMS1137 (48 weeks). Mood and
suicidality were assessed using the Beck Depression Inventory-II
(BDI-II). In GWMS1137, suicidality was additionally assessed using
the Columbia-Suicide Severity Rating Scale (C-SSRS) and working
memory/processing speed was assessed using the Paced Auditory
Serial Addition Test (PASAT). Results of the analysis showed that
nabiximols had no notable negative effects on cognition,
depression, or suicidality.
“Concerns related to the mental health impact of
unregulated cannabinoid therapies remain and this analysis sought
to determine whether nabiximols had any such risks within the MS
populations studied,” said Dr. John DeLuca, Senior Vice President
for Research, Kessler Foundation, and Professor, Department of
Physical Medicine & Rehabilitation and of Neurology, Rutgers
New Jersey Medical School. “The results are promising and show that
nabiximols, a well-studied cannabinoid therapy, did not increase
the risk of cognitive impairment, depression, or suicide.”
GW, and its U.S. subsidiary Greenwich
Biosciences, plan to advance the nabiximols clinical development
program in the U.S. with five pivotal Phase 3 trials through the
end of 2020 and into 2021.
About NabiximolsNabiximols is
expected to enter pivotal Phase 3 development in the United States
in the second half of 2020. The U.S. commercial rights are owned by
GW. GW anticipates developing multiple indications for nabiximols
with an initial target indication for the treatment of MS
spasticity, to be followed by Spinal Cord Injury spasticity and
Post Traumatic Stress Disorder, or PTSD.
Nabiximols is a complex botanical medicine
formulated from extracts of the cannabis plant that contains the
principal cannabinoids THC and CBD and also contains minor
constituents, including other cannabinoid and non-cannabinoid plant
components, such as terpenes, sterols, and triglycerides. The
product is administered as an oral spray.
Nabiximols is known as Sativex® outside of the
United States and is indicated in numerous countries as a treatment
for symptom improvement in adult patients with moderate to severe
spasticity due to multiple sclerosis (MS) who have not responded
adequately to other anti-spasticity medication and who demonstrate
clinically significant improvement in spasticity related symptoms
during an initial trial of therapy.1 These approvals were based on
multiple pivotal trials conducted in Europe.2 Sativex is currently
not approved for any indication in the U.S.
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 is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous
sclerosis complex (TSC) in patients one year of age and older. This
product has received approval in the European Union under the
tradename EPIDYOLEX® for the adjunctive treatment of seizures
associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in
conjunction with clobazam in patients two years and older and is
under EMA review for the treatment of TSC. The Company is also
carrying out a Phase 3 trial in Rett syndrome and has a deep
pipeline of additional cannabinoid product candidates, including
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 statementThis
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding the timing of clinical trials, the timing of regulatory
filings and approvals, the timing and outcomes of regulatory or
intellectual property decisions, and the clinical benefits and
commercial potential of nabiximols (marketed as
Sativex® outside the US). Actual events could differ
materially from those projected herein and depend on a number of
factors, including (inter alia), the risks and uncertainties which
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 |
|
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U.S. Media Enquiries: |
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Sam Brown Inc. Healthcare Communications |
|
Christy Curran |
615 414 8668 |
Mike Beyer |
312 961 2502 |
1 Sativex Oralmucosal Spray, SmPC,
https://www.medicines.org.uk/emc/product/602.
2 Markova et al, International Journal of Neuroscience 2019;
Novotna et al, European Journal of Neurology 2011; Collin et al,
European Journal of Neurology 2007About Nabiximols
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