Positive V3381 Phase IIa results
16 July 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.
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| 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 |
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® | 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® and Apokyn®, 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 II | Phase III | Registration | Market | Marketing Rights |
| Apokyn® | Parkinson’s Disease | x | North America | ||||
| Frova® | Migraine | x | US milestones & royalties -
Endo (EU – royalties) | ||||
| Frova® | Menstrual Migraine Prevention | x | US milestones & royalties -
Endo (EU – royalties) | ||||
| V1512 | Parkinson’s Disease | x | Worldwide (excl. Italy) | ||||
| V10153 | Ischaemic stroke | x | Worldwide | ||||
| V1003 | Acute Pain | x | US Profit share
Option Reckitt Benckiser | ||||
| V3381 | Neuropathic Pain | x | Worldwide | ||||
| V2006 | Parkinson’s Disease | x | US Co-promotion Biogen Idec | ||||
| MMPI | Multiple Sclerosis | x | Royalties - Serono | ||||
| V24343 | Obesity | x | Worldwide |
Vernalis has established a US commercial operation to promote Apokyn ® and co-promote Frova ® 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® and Apokyn® 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.
