Vernalis Announces Striking Weight Loss in Phase I Study with V24343 in Overweight and Mildly Obese Volunteers
LONDON, Sept. 13, 2007-Vernalis plc (LSE: VER) today announced the results of its Phase I programme with the CB1 antagonist, V24343 which has completed two Phase I studies: a single and multiple ascending dose study for up to 14 days, and a food effect study.- Striking weight loss over 16 days in overweight and mildly obese volunteers
- Evaluated in a total of 66 volunteers
- Generally well tolerated with no serious adverse events
- Evidence of efficacy also demonstrated by clinically relevant reductions in body fat, energy intake and waist circumference
- Pre-clinical data demonstrated significant safety differences from Sanofi-aventis CB1 antagonist, rimonabant.
Simon Sturge, CEO of Vernalis commented "We are very excited by
these preliminary results which, if confirmed over longer
studies, will be of significant benefit to overweight and obese
patients. We stated from the outset of this trial that it is
our intention to seek a partner for this programme, a process which
is enhanced by such promising data".
Safety and Tolerability
V24343 was generally well tolerated over the dose range with two
patients withdrawing due to adverse events (nausea and vomiting) in
the highest dose cohorts. Other tolerability events were as
expected for a CB1 antagonist. There were no serious adverse
events.
Efficacy
Measures of efficacy were taken in the multiple ascending dose
study in which patients were treated at 4 daily dose levels of 5mg,
15mg, 50mg and 100mg. In this trial, there were clear beneficial
effects of V24343 at all dose levels across multiple parameters
including weight loss, waist circumference, body fat and energy
intake.
Average weight loss after 16 days was 0.5kg for placebo, 2.6kg for
5mg V24343 and 5.0kg for 100mg V24343. This compares very
favourably with results for rimonabant in a similar trial in obese
volunteers over 1 week, which showed placebo-corrected weight loss
of 0.7kg.
Differentiation from Rimonabant
The striking weight loss demonstrated in the Phase I study above
gives further credence to the effectiveness of CB1 antagonists as
weight loss agents. The U.S. Food and Drug Administration (FDA)
advisory committee decision to not support the approval of
rimonabant for a number of reasons, including risks associated with
depression, may be relevant to this class of drug. However, the
question as to whether or not other CB1 antagonists can achieve
similar or improved efficacy without major side effects remains
open. Indeed, V24343 has shown a number of
distinguishing features over rimonabant in pre-clinical studies
including:
-A markedly reduced propensity for neurological
adverse events
-Lower propensity to induce nausea and GI
disturbance
-Improved metabolic profile.
More lengthy trials will be required to evaluate fully the
long-term safety and
efficacy of this product in the treatment of obesity and other
indications such
as management of diabetes.
-- ends --
Enquiries:
Vernalis
plc
+44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
Brunswick
Group
+44 (0) 20 7404 5959
Jon Coles
Justine McIlroy
Alex Tweed
Lazar Partners Ltd
Gregory
Gin
+1 212-867-1762
Notes to Editors
About Vernalis
Vernalis is a speciality bio-pharmaceutical company focused on
products marketed
to specialist neurologists. The company has two marketed products,
Frova(R) and
Apokyn(R), and a development pipeline focused on neurology and
central nervous
system disorders. The company has seven products in clinical
development and
collaborations with leading, global pharmaceutical companies
including Novartis,
Biogen Idec, Serono and Chiesi:
Product Indication Phase I Phase
Phase Registration Market Marketing Rights
II III
Apokyn(R)
Parkinson's
X North America
Disease
Frova(R)
Acute
X US Co-promotion
Migraine
Endo
(EU-royalties
Menarini)
Frova(R)
Menstrual
X
US Co-promotion
Migraine
Endo
Prevention
(EU-royalties
Menarini)
V1512
Parkinson's
X
World Wide (excl.
Disease
Italy)
V10153
Ischaemic
X
World Wide
Stroke
V3381
Neuropathic
X
World Wide
Pain
V2006
Parkinson's
X
US Co-promotion
Disease
Biogen Idec
V24343
Obesity
X
World Wide
Hsp90
Cancer
X
Royalty
(Novartis)
MMPI
Multiple
X
Royalty (Serono)
Sclerosis
Vernalis has established a US commercial operation to promote
Apokyn (R) and
co-promote Frova (R) alongside its North American licensing
partner, Endo
Pharmaceuticals, propelling the company towards its goal of
becoming a
sustainable, self-funding, R&D-driven, speciality
bio-pharmaceutical company.
For further information about Vernalis, please visit
www.vernalis.com.
About V24343
Scientists have long known that cannabis, which stimulates a
receptor in the
brain called the CB1 receptor, also stimulates appetite as
evidenced by the
hunger pangs or "munchies" often experienced by cannabis
smokers. Blockade of
these CB1 receptors by products like V24343 has been shown to cause
weight loss
and may reduce risk factors for obesity related disorders such as
cardiovascular
disease and type II diabetes.
About Obesity
Obesity, defined as a body mass index of greater than 30, arises
from the
accumulation of excess fat in the body from over consumption of
fatty foods
According to the American Obesity Association, obesity is a disease
that affects
nearly one-third of the adult American population (approximately 60
million).
The number of overweight and obese Americans has continued to
increase since
1960, a trend that is not slowing down. Today, 64.5 percent of
adult Americans
(about 127 million) are categorized as being overweight or obese.
Each year,
obesity causes at least 300,000 excess deaths in the U.S., and
healthcare costs
of American adults with obesity amount to approximately $100
billion. The World
Health Organisation state that obesity is a major contributor to
the global
burden of chronic disease and disability and has reached epidemic
proportions
globally, with more than one billion adults overweight, at least
300 million of
them being classed as clinically obese. People with obesity
are at risk of
developing one or more serious medical conditions, which can cause
poor health
and premature death. Obesity is associated with more
than 30 medical
conditions including diabetes, heart disease and high blood
pressure and
scientific evidence has established a strong relationship with at
least 15 of
those conditions.
Forward-Looking Statement
This news release may contain forward-looking statements that
reflect the
Company's current expectations regarding future events including
the clinical
development and regulatory clearance of the Company's products, the
Company's
ability to find partners for the development and commercialisation
of its
products, as well as the Company's future capital raising
activities.
Forward-looking statements involve risks and uncertainties. Actual
events could
differ materially from those projected herein and depend on a
number of factors
including the success of the Company's research strategies, the
applicability of
the discoveries made therein, the successful and timely completion
of clinical
studies, the uncertainties related to the regulatory process, the
ability of the
Company to identify and agree beneficial terms with suitable
partners for the
commercialisation and/or development of its products, as well as
the achievement
of expected synergies from such transactions, the acceptance of
Frova(R) and
Apokyn(R) and other products by consumers and medical
professionals, the
successful integration of completed mergers and acquisitions and
achievement of
expected synergies from such transactions, and the ability of the
Company to
identify and consummate suitable strategic and business
combination
transactions.
Posted: September 2007
