SUMM.L Regulatory News (SUMM)

16 Jan 2008 07:01

Summit Corporation PLC16 January 2008 Summit Corporation plc("Summit plc" or "the Company") SUMMIT PLC'S LEAD DRUG CANDIDATE ENTERS PHASE II CLINICAL TRIALSCandidate targets sialorrhoea, a symptom of Parkinson's disease Oxford, UK, 16 January 2008 - Summit Corporation plc (AIM: SUMM), a leading UKbiotechnology company, announces that is has started a Phase II proof of conceptclinical trial of its small molecule drug candidate SMT D001 for the treatmentof sialorrhoea. Sialorrhoea is a common and distressing symptom of Parkinson's diseasecharacterised by the overproduction of saliva and uncontrollable drooling. Thiscondition is also a symptom of several other diseases including cerebral palsy,stroke, muscular dystrophy and oesophageal cancer. The estimated treatablepopulation within the major pharmaceutical markets (US, EU, Japan, Canada andAustralia) is in excess of three million patients. The Phase II clinical trial is: • A randomised, double-blind, placebo-controlled trial being conducted in the United Kingdom; • Being conducted in a total of 40 Parkinson's patients; patients will be treated in cohorts of ten and dosed over ten-week periods; and, • Aiming to establish proof of concept for SMT D001 as a combination therapy with a reduction in saliva secretion rates being measured as the primary end point for the trial. Summit has received approval to commence the trial from the UK's Medicines andHealthcare products Regulatory Agency (MHRA) and has begun the patientrecruitment process. The Company expects to announce first results from thisclinical trial in Q3 of 2008 after completing dosing in all 40 patients.Additional trials to investigate and optimise the formulation of SMT D001 willfollow on from this current trial. Results from an earlier Phase I studyconducted in nine healthy volunteers demonstrated saliva suppression levels ofup to 40%. SMT D001 has been developed using Summit's drug re-profiling expertise and is acombination therapy designed to reduce saliva production that exploits thewell-known side-effects of two off-patent drugs with an established history ofsafe use. In additional to SMT D001, Summit has a second re-profiled,early-stage clinical programme targeting the symptoms of Parkinson's disease.SMT D002 is being developed as a novel treatment for seborrhoea (excessive sebumproduction). Seborrhoea is also believed to be the primary cause of acne andSMT D002 is currently in a Phase I clinical trial with the results expectedduring Q1 2008. Steven Lee, PhD, Chief Executive Officer of Summit, said "Drug re-profilingprogrammes such as SMT D001 provide the opportunity to identify and developnovel indications for known drugs in a quick and cost-effective manner. Thestart of this Phase II clinical trial and the progress being made by SMT D002 isadding further to the value of both these programmes as Summit actively seeks tosign attractive commercial licensing deals." - ENDS - For more information, please contact: Summit plc Steven Lee, PhD, Chief Executive Officer Tel: +44 (0)1235 443951Darren Millington, ACMA, Chief Financial OfficerRichard Pye, PhD, Investor Relations Citigate Dewe Rogerson Mark Swallow, PhD / David Dible Tel: +44 (0)207 638 9571 Panmure Gordon Andrew Burnett / Rakesh Sharma Tel: +44 (0)207 459 3600 About Summit plc Summit plc is a leading UK biotechnology company that discovers and developsproprietary new drugs. The Company's internal drug development programmes areunderpinned by its advanced carbohydrate chemistry and drug screening (chemicalgenomics) technology platforms, which it also provides on a collaborative orfee-for-service basis to the pharmaceutical industry. Summit plc has a broad range of drug discovery programmes in the clinical,pre-clinical and discovery stages of development, which target serious diseaseswith a high unmet medical need. These therapeutic areas include neuro-disorders(neurodegenerative and neuromuscular), anti-infectives, ophthalmic diseases,oncology and regenerative medicines. Summit plc's in-house drug development capabilities combine world-classexpertise in both carbohydrate chemistry with high-volume, high-contentscreening using its proprietary zebrafish and fruitfly technologies (chemicalgenomics). These whole organism screens have the potential to dramaticallydecrease the time and cost of drug discovery and development by delivering datathat are highly predictive of the efficacy and toxicity of potential drugcompounds in humans. The company listed on the AIM market of the London Stock Exchange in October2004 - symbol: SUMM Further information about the company is available at www.summitplc.com This information is provided by RNS The company news service from the London Stock Exchange