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
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.
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).
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
Frova Migraine X US Co-promotion Endo
(R) (EU - royalties)
Frova Menstrual X US Co-promotion Endo
(R) Migraine (EU - royalties)
V1512 Parkinson's X World Wide (excl.
V10153 Thrombotic X World Wide
V1003 Acute Pain X US Profit share
V3381 Neuropathic X World Wide
V2006 Parkinson's X US Co-promotion
Disease Biogen Idec
MMPI Multiple X None - royalty
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.
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.
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
Lazar Partners Ltd
Gregory Gin +1 212-867-1762
Posted: July 2007