Vernalis Reports Positive Outcome of a Phase IIA Trial of V3381 In Diabetic Neuropathic Pain
WINNERSH, England, July 16, 2007- Vernalis plc (LSE: VER) today
announced the headline results from its Phase IIa trial of
V3381. The trial was designed to assess safety and
pharmacokinetics while providing a preliminary indication of
efficacy in patients suffering from neuropathic pain
resulting from long-standing diabetes.
- V3381 was generally well-tolerated
- Good preliminary indications of efficacy
- Headline data warrant progression into the next stage of
clinical
development
Trial Design
The study was a randomised, double-blind, placebo-controlled,
crossover Phase IIa clinical trial designed to assess safety,
pharmacokinetics and preliminary efficacy of repeat dosing
with V3381, in development for the treatment of neuropathic
pain. The study was conducted in five specialist centres in the
United States and Canada with 35 patients completing both treatment
periods. The study was conducted in three stages:
Period 1 Patients were randomised to either treatment
with V3381 (2 weeks at 200mg twice daily followed by 2 weeks
at 400 mg twice daily) or matching placebo (4 weeks).
Wash-out All patients then went through a one week wash
out prior to Period 2.
Period 2 Patients then "crossed over" to the alternate
therapy; i.e., patients treated with V3381 in Period 1 were treated
with placebo and patients on Placebo in Period 1 were treated
with V3381 (2 weeks at 200mg twice daily followed by 2 weeks
at 400 mg twice daily).
Safety and Tolerability
V3381 was generally well tolerated with 46 patients being
randomised into the study and 35 patients completing both
treatment periods. Ten patients dropped out because of
adverse events, of which three were on placebo and seven were
on V3381. One patient on placebo withdrew consent. There were
three serious adverse events during the course of the trial of
which two were in the treated group
with one thought to be possibly related to treatment. The most
common adverse events reported by patients were consistent with
previous experience with the drug in Phase I studies, with
dizziness and nausea being the most frequent.
Evidence of Efficacy
The primary efficacy endpoint was the change from baseline in the
11-point Likert Numerical Pain Rating Scale, recorded by
patients in daily diaries.
Positive indications of efficacy were observed in the primary
efficacy endpoint during Period 1 and these are supported by clear
positive trends demonstrated in a number of secondary end points in
the overall analysis of both treatment periods. These data support
progression to the next stage of clinical development.
In Period 1 of the trial there was a positive indication in the
primary efficacy endpoint with patients on V3381 having a
greater reduction in their Likert score than patients on placebo.
However, inconsistencies were observed during the wash-out period
as patients who had been on V3381 in Period 1 reported an expected
increase in their Likert score during the washout period but
patients
who had been on placebo during Period 1 showed an unexpected
reduction in their Likert score during the washout. As a result the
difference between the two treatment groups was not as clear during
Period 2.
The secondary efficacy endpoint data was generally more consistent
between treatment periods and there were clear trends towards
efficacy in the overall analysis of both treatment periods with
some measures reaching statistical significance.
Conclusion
Dr John Hutchison, Vernalis' Development Director and Chief Medical
Officer, commented: "The safety and efficacy results of this Phase
IIa trial are encouraging and it is promising to see trends of
efficacy across a range of pain measures"
Simon Sturge, CEO of Vernalis added:
"I am very encouraged by the results of this trial and Vernalis
looks forward to progressing V3381 into further clinical
development in what is a challenging and poorly treated
condition."
V3381 is a novel drug candidate which has a dual mechanism of
action targeting both the central and peripheral nervous systems
and for which Vernalis has worldwide rights.
Notes to Editors
Neuropathic pain is a chronic form of pain related to damage to
nerves and their signalling processes, and unlike other forms of
pain, is generally non-responsive to current analgesics, does not
diminish over time and can increase in both intensity and area.
This type of pain occurs in later stages of diabetes, post-herpetic
neuralgia (shingles), side effects of chemotherapy, trigeminal
(facial) neuralgia, HIV infection, spinal cord injuries and other
nerve injuries (eg. amputation).
About Vernalis
Vernalis has significant product development milestones during
2007
Frova(R) MM PDUFA date 19 August 2007
V10153 Phase IIa data
V24343 Phase I data
V1512 Start Phase
III
Hsp90 Start clinical
testing
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 Phase Phase Registration
Market Marketing Rights
I II III
Apokyn
Parkinson's
X North America
(R) Disease
Frova
Migraine
X US Co-promotion Endo
(R)
(EU - royalties)
Frova
Menstrual
X
US Co-promotion Endo
(R)
Migraine
(EU - royalties)
Prevention
V1512
Parkinson's
X
World Wide (excl.
Disease
Italy)
V10153
Thrombotic
X
World Wide
Disorders
V1003 Acute
Pain
X
US Profit share
Option Reckitt
Benckiser
V3381
Neuropathic
X
World Wide
Pain
V2006
Parkinson's
X
US Co-promotion
Disease
Biogen Idec
MMPI
Multiple
X
None - royalty
Sclerosis
(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.
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.
Enquiries:
Vernalis
plc
+44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
John Hutchison, Development Director
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
Posted: July 2007
