16th Jul 2007 07:01
Vernalis PLC16 July 2007 16 July 2007 VERNALIS REPORTS POSITIVE OUTCOME OF A PHASE IIA TRIAL OF V3381 IN DIABETIC NEUROPATHIC PAIN Vernalis plc (LSE: VER) today announced the headline results from its Phase IIatrial of V3381. The trial was designed to assess safety and pharmacokineticswhile providing a preliminary indication of efficacy in patients suffering fromneuropathic 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 PhaseIIa clinical trial designed to assess safety, pharmacokinetics and preliminaryefficacy of repeat dosing with V3381, in development for the treatment ofneuropathic pain. The study was conducted in five specialist centres in theUnited States and Canada with 35 patients completing both treatment periods. Thestudy 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 thestudy and 35 patients completing both treatment periods. Ten patients droppedout because of adverse events, of which three were on placebo and seven were onV3381. One patient on placebo withdrew consent. There were three serious adverseevents during the course of the trial of which two were in the treated groupwith one thought to be possibly related to treatment. The most common adverseevents reported by patients were consistent with previous experience with thedrug 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-pointLikert Numerical Pain Rating Scale, recorded by patients in daily diaries. Positive indications of efficacy were observed in the primary efficacy endpointduring Period 1 and these are supported by clear positive trends demonstrated ina number of secondary end points in the overall analysis of both treatmentperiods. These data support progression to the next stage of clinicaldevelopment. In Period 1 of the trial there was a positive indication in the primary efficacyendpoint with patients on V3381 having a greater reduction in their Likert scorethan patients on placebo. However, inconsistencies were observed during thewash-out period as patients who had been on V3381 in Period 1 reported anexpected increase in their Likert score during the washout period but patientswho had been on placebo during Period 1 showed an unexpected reduction in theirLikert score during the washout. As a result the difference between the twotreatment groups was not as clear during Period 2. The secondary efficacy endpoint data was generally more consistent betweentreatment periods and there were clear trends towards efficacy in the overallanalysis of both treatment periods with some measures reaching statisticalsignificance. Conclusion Dr John Hutchison, Vernalis' Development Director and Chief Medical Officer,commented: "The safety and efficacy results of this Phase IIa trial areencouraging and it is promising to see trends of efficacy across a range of painmeasures" Simon Sturge, CEO of Vernalis added: "I am very encouraged by the results of this trial and Vernalis looks forward toprogressing V3381 into further clinical development in what is a challenging andpoorly treated condition." V3381 is a novel drug candidate which has a dual mechanism of action targetingboth the central and peripheral nervous systems and for which Vernalis hasworldwide rights. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerJohn Hutchison, Development DirectorTony Weir, Chief Financial Officer Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroyAlex Tweed Lazar Partners LtdGregory Gin +1 212-867-1762 Notes to Editors Neuropathic pain is a chronic form of pain related to damage to nerves and theirsignalling processes, and unlike other forms of pain, is generallynon-responsive to current analgesics, does not diminish over time and canincrease in both intensity and area. This type of pain occurs in later stages ofdiabetes, post-herpetic neuralgia (shingles), side effects of chemotherapy,trigeminal (facial) neuralgia, HIV infection, spinal cord injuries and othernerve injuries (eg. amputation). About Vernalis Vernalis has significant product development milestones during 2007 Frova(R) MM PDUFA date 19 August 2007V10153 Phase IIa dataV24343 Phase I dataV1512 Start Phase IIIHsp90 Start clinical testing Vernalis is a speciality bio-pharmaceutical company focused on products marketedto specialist neurologists. The company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has seven products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec, Serono and Chiesi: Product Indication Phase Phase Phase Registration Market Marketing Rights I II IIIApokyn 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) andco-promote Frova (R) alongside its North American licensing partner, EndoPharmaceuticals, propelling the company towards its goal of becoming asustainable, 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 theCompany's current expectations regarding future events including the clinicaldevelopment and regulatory clearance of the Company's products, the Company'sability to find partners for the development and commercialisation of itsproducts, as well as the Company's future capital raising activities.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the ability of theCompany to identify and agree beneficial terms with suitable partners for thecommercialisation and/or development of its products, as well as the achievementof expected synergies from such transactions, the acceptance of Frova(R) andApokyn(R) and other products by consumers and medical professionals, thesuccessful integration of completed mergers and acquisitions and achievement ofexpected synergies from such transactions, and the ability of the Company toidentify and consummate suitable strategic and business combinationtransactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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