Vernalis completes recruitment in V3381 Phase II IN-STEP study for neuropathic pain
15 September 2009
Vernalis plc (LSE: VER) today announces it has completed patient enrolment into the randomised phase of the V3381 (indantadol) Phase II IN-STEP study. The study, evaluating further the safety and efficacy of indantadol in patients with neuropathic pain due to diabetes, is being conducted at sites in the US, Canada, UK and Czech Republic. Headline data is expected in the first half of 2010.
Neuropathic pain is a type of pain caused by damage to the nervous system. There are numerous different causes of this damage, with diabetes, herpes (shingles) infection and nerve trauma being some of the more common. It has been estimated to affect between 1 and 7 per 100 individuals in the US and Europe, but is a syndrome that is often under-diagnosed and so under-treated. It is typically described as burning, stabbing, shooting or aching and can be very debilitating. Traditional analgesics are often ineffective and many patients remain poorly treated.
Studies in neuropathic pain are challenging and traditionally show a high placebo response. The V3381 IN-STEP study was designed with an innovative placebo run-in period which aims to minimise the confounding effects of patients who are marked placebo-responders.
\"We are delighted to have achieved this important milestone for Vernalis and to have beaten our stated goal of full enrolment by the end of the year. By completing recruitment ahead of target we now expect headline study results in the first half of 2010, also earlier than previously announced\" said Ian Garland, CEO of Vernalis.
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|Ian Garland, Chief Executive Officer||+44 (0) 118 989 9360|
|David Mackney, Chief Financial Officer|
|Jon Coles||+44 (0) 20 7404 5959|
Notes to Editors
Vernalis is a development stage pharmaceutical company with significant expertise both in de novo fragment and structure-based drug discovery and pre-clinical and clinical development. The Group has seven product candidates in clinical development (three of which are partnered), two programmes in pre-clinical, as well as other competitive research programmes. Our technologies, capabilities and products are endorsed by collaborations with leading, global pharmaceutical companies including GSK, Biogen Idec, Novartis, Servier, Chiesi, Menarini, and Endo.
|Product||Indication||Pre-Clinical||Phase I||Phase II||Phase III||Marketing Rights|
|V2006||Parkinson's Disease||X||Biogen Idec|
|Progress through partnering|
For further information about Vernalis, please visit www.vernalis.com
Vernalis 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 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.