Vernalis Announces Striking Weight Loss in Phase I Study with V24343 in Overweight and Mildly Obese VolunteersLONDON, 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.
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.
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Vernalis plc +44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
Brunswick Group +44 (0) 20 7404 5959
Lazar Partners Ltd
Gregory Gin +1 212-867-1762
Notes to Editors
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
Apokyn(R) Parkinson's X North America
Frova(R) Acute X US Co-promotion
Frova(R) Menstrual X US Co-promotion
V1512 Parkinson's X World Wide (excl.
V10153 Ischaemic X World Wide
V3381 Neuropathic X World Wide
V2006 Parkinson's X US Co-promotion
Disease Biogen Idec
V24343 Obesity X World Wide
Hsp90 Cancer X Royalty
MMPI Multiple X Royalty (Serono)
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.
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.
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
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
Posted: September 2007