Summit Corp plc -- Lead drug candidate enters Phase II clinical trials
16 Jan 2008
Candidate targets sialorrhoea, a symptom of Parkinson's disease
Summit Corporation plc (AIM: SUMM), a leading UK biotechnology company, announces that is has started a Phase II proof of concept clinical trial of its small molecule drug candidate SMT D001 for the treatment of sialorrhoea.
Sialorrhoea is a common and distressing symptom of Parkinson's disease characterised by the overproduction of saliva and uncontrollable drooling. This condition is also a symptom of several other diseases including cerebral palsy, stroke, muscular dystrophy and oesophageal cancer. The estimated treatable population within the major pharmaceutical markets (US, EU, Japan, Canada and Australia) 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 and Healthcare products Regulatory Agency (MHRA) and has begun the patient recruitment process. The Company expects to announce first results from this clinical trial in Q3 of 2008 after completing dosing in all 40 patients. Additional trials to investigate and optimise the formulation of SMT D001 will follow on from this current trial. Results from an earlier Phase I study conducted in nine healthy volunteers demonstrated saliva suppression levels of up to 40%.
SMT D001 has been developed using Summit's drug re-profiling expertise and is a combination therapy designed to reduce saliva production that exploits the well-known side-effects of two off-patent drugs with an established history of safe 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 sebum production). Seborrhoea is also believed to be the primary cause of acne and SMT D002 is currently in a Phase I clinical trial with the results expected during Q1 2008.
Steven Lee, PhD, Chief Executive Officer of Summit, said: "Drug re-profiling programmes such as SMT D001 provide the opportunity to identify and develop novel indications for known drugs in a quick and cost-effective manner. The start of this Phase II clinical trial and the progress being made by SMT D002 is adding further to the value of both these programmes as Summit actively seeks to sign attractive commercial licensing deals."
For more information, please contact:
Summit plc
Steven Lee, PhD, Chief Executive
Officer
Tel: +44 (0)1235 443951
Darren Millington, ACMA, Chief Financial Officer
Richard 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 develops proprietary new drugs. The Company's internal drug development programmes are underpinned by its advanced carbohydrate chemistry and drug screening (chemical genomics) technology platforms, which it also provides on a collaborative or fee-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 diseases with 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-class expertise in both carbohydrate chemistry with
high-volume, high-content screening using its proprietary zebrafish
and fruitfly technologies (chemical genomics). These whole organism
screens have the potential to dramatically decrease the time and
cost of drug discovery and development by delivering data that are
highly predictive of the efficacy and toxicity of potential
drug
compounds in humans.
The company listed on the AIM market of the London Stock Exchange in October 2004 - symbol: SUMM
Further information about the company is available at www.summitplc.com
