Oxford-based biotechnology group Summit plc has kicked off a Phase II trial investigating the potential of its lead drug candidate SMT D001 as a treatment of sialorrhoea.

Sialorrhoea is a common symptom of Parkinson’s disease and is characterised by the overproduction of saliva and uncontrollable drooling, but also occurs as a result of several other conditions such as cerebral palsy, stroke, muscular dystrophy and oesophageal cancer.

The Phase II, randomised, placebo-controlled, UK-based trial aims to enrol around 40 patients with Parkinson’s disease, and has a primary endpoint of a significant reduction in the secretion of saliva, following on from Phase I studies which showed the agent cut saliva production by around 40%. Preliminary findings should be reported in the third quarter of this year, the group said.

Solid potential
SMT D001 is basically a reformulation of two undisclosed, “off-patent drugs with a history of safe use”, and the company is certainly excited about its potential, given that the estimated treatable population with the condition in the major pharmaceutical markets - the US, European Union, Japan, Canada and Australia - is more than three million.

“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,” commented Steven Lee, PhD, Chief Executive Officer of Summit. “The start of this Phase II clinical trial and the progress being made by SMT D002 [in trials for excessive sebum production] is adding further to the value of both these programmes as Summit actively seeks to sign attractive commercial licensing deals.”