GW Pharmaceuticals GWP PhIIa Study Identifies New Anti-Diabetic Treatment

  GW Pharmaceuticals (GWP) - PhIIa Study Identifies New Anti-Diabetic

RNS Number : 1575S
GW Pharmaceuticals PLC
28 November 2012


   Results from GW Phase IIa Study Identify Promising New Oral Cannabinoid
                           Anti-Diabetic Treatment

Porton Down, UK;  November 28  2012:GW Pharmaceuticals  plc (AIM:GWP)  reports 
results from a  Phase IIa exploratory  study which has  identified GW's  novel 
cannabinoid, GWP42004, as a potential new oral treatment for type 2  diabetes. 
In the study,  which examined  a number  of clinically  relevant endpoints  in 
patients with type 2 diabetes, GWP42004, an oral cannabinoid treatment, showed
consistent evidence of anti-diabetic effects.

Dr Garry Tan,  formerly of  the University  of Nottingham  and now  Consultant 
Physician  at  NIHR  Biomedical  Research  Centre  in  theOxford  Centre  for 
Diabetes, Endocrinology & Metabolism, and the study's Principal  Investigator, 
said, "The positive findings from this early stage exploratory study are  very 
encouraging. Even  in small  numbers of  patients, GWP42004  shows  consistent 
evidence of anti-diabetic effects. The data clearly support advancing GWP42004
into further clinical development. If  larger studies confirm these  findings, 
GWP42004 would  have  the  potential  to  offer  a  novel  orally-administered 
treatment option within one of the largest therapeutic areas where there still
exist serious unmet medical needs."

This 5-arm study was a 13  week randomised, double blind, placebo  controlled, 
parallel group,  pilot  study of  GWP42004  (5mg), GWP42003  (100mg)  and  two 
separate ratios (5mg:5mg and  100mg:5mg) of GWP42003:GWP42004. Each  treatment 
was formulated as oral capsules and administered twice daily.

The exploratory study enrolled  a total of 62  type 2 diabetes patients,  such 
that each treatment group  had 11-14 patients. Due  to this small sample  size 
per group, 10% statistical significance  levels were applied (i.e. p<0.1)  and 
identification of consistent  trends were  considered a key  objective of  the 

The study has  identified GWP42004  as the  company's lead  candidate in  this 
therapeutic area and showed that it has the following desirable  anti-diabetic 

Statistically significant results:

· Reduced  fasting plasma  glucose levels  (p=0.04), with  an increase  in 
fasting insulin.

· Improved pancreatic beta-cell function (p=0.0074).

· Increased serum adiponectin (p=0.0024)  - an increase in adiponectin  is 
considered desirable.

· Reduced systolic  blood pressure  (p=0.099) -  a desirable  effect in  a 
patient population with increased cardiovascular morbidity.

· Reduced serum  IL-6 levels  (p=0.076) - the  inflammatory cytokine  IL-6 
been proposed  to  affect  glucose homeostasis  and  metabolism  directly  and 
indirectly by  action  on  skeletal  muscle  cells,  adipocytes,  hepatocytes, 
pancreatic β-cells, and neuroendocrine cells).

Positive trends:

· Increased insulin  sensitivity: (+4.99  change for GWP42004  vs a  -4.26 
change for placebo, non-significant trend p>0.1).

· Raised GLP-1 (62% increase from baseline, non-significant trend  p>0.1), 
GLP-1 (glucagon-like peptide-1)  is a  natural hormone  that mediates  insulin 
secretion in a glucose dependent manner. In type 2 diabetics, GLP-1 levels are
reduced leading to both  poor insulin secretion  and reduced pancreatic  islet 
insulin content.

· Reduced serum  C-Reactive Protein  (CRP) levels (p=0.1)  - Elevation  of 
C-reactive protein  (CRP) is  associated  with an  increased risk  of  insulin 

Several of these findings are  consistent with pre-clinical data generated  in 
collaboration with  Professor  Mike Cawthorne  at  the GW  Metabolic  Research 
Laboratory, University of  Buckingham. In particular,  pre-clinical data  show 
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.

Although patient numbers in the study are small, the data offer the hypothesis
that the mechanism of actionfor GWP42004 may be that it acts as an oral GLP-1
(glucagon-like peptide-1)  secretagogue.  GW  plans  to  undertake  additional 
research to further  evaluate this hypothesis.  Injectable GLP-1 agonists  are 
emerging as an important new class of  treatment to treat type 2 diabetes  and 
an oral product that stimulates GLP-1 release is likely to be attractive  both 
to patients and to the pharmaceutical industry.

The study  did  not  show  meaningful  effects  for  GWP42003  and  the  other 
cannabinoid ratios. There was also no improvement in the pre-specified primary
endpoint of HDL  cholesterol, an  endpoint which  had been  selected based  on 
pre-clinical data for  GWP42003. These  study findings  therefore achieve  the 
important objective  of identifying  GWP42004 as  the lead  candidate in  this 
therapeutic area  and  allowing  GW  to direct  future  GWP42004  research  on 
anti-diabetes endpoints.

The study drugs were well-tolerated, with only 4 patients withdrawing from the
study due  to  adverse  events.  Overall, a  slightly  greater  proportion  of 
patients experienced adverse  events on  placebo than  on study  drug (93%  vs 

Dr Stephen Wright,  GW's R&D  Director, said, "We  are very  pleased that  the 
promising results seen  for GWP42004  in our pre-clinical  research have  been 
borne out in this first early proof of principle clinical trial. Key  findings 
include the preservation of beta cell function and evidence across a number of
endpoints suggesting  an increase  in insulin  sensitivity. GW  will now  move 
ahead to  explore  the  clinical  relevance  of  the  desirable  anti-diabetic 
features of GWP42004  across a range  of doses in  a larger Phase  2 study  in 


GW Pharmaceuticals plc              (Today) +44 20 7831 3113
Dr Geoffrey Guy, Chairman       (Thereafter) +44 1980 557000
Justin Gover, Managing Director
FTI Consulting                              +44 20 7831 3113
Ben Atwell / John Dineen
  Peel Hunt LLP                           +44 20 7418 8900
  James Steel / Vijay Barathan                           

Notes to Editors:

About GW

GW was founded in  1998 and listed on  the AIM, a market  of the London  Stock 
Exchange, in June 2001. Operating under  license from the UK Home Office,  the 
company  researches  and  develops  cannabinoid  pharmaceutical  products  for 
patients who suffer from a range  of serious ailments, in particular  multiple 
sclerosis and cancer pain. GW has  assembled a large in-house scientific  team 
with expertise in cannabinoid science as well as experience in the development
of  both  plant-based  prescription  pharmaceutical  products  and   medicines 
containing controlled  substances. GW  occupies a  world leading  position  in 
cannabinoids and has developed an extensive international network of the  most 
prominent scientists  in  the field.  For  further information,  please  visit

                     This information is provided by RNS
           The company news service from the London Stock Exchange


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