Summit's lead drug candidate enters phase II clinical trials

Candidate targets sialorrhoea, a symptom of Parkinson's disease

17-Jan-2008

Summit Corporation plc announced 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. The aim is 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.

https://www.bionity.com/en/news/76625/summit-s-lead-drug-candidate-enters-phase-ii-clinical-trials.html