NeuroSolutions appoints Sigma Aldrich for scale-up

NeuroSolutions, the UK based subsidiary of newly listed neurology-focused biotech company NeuroDiscovery (ASX:NDL) has identified and selected Sigma Aldrich to provide scale-up and manufacturing services in relation to its lead pain drug candidate, NSL-043, which is due to enter a phase I clinical trial later this year.

NSL-043 has previously been developed by a Japanese company as an antirheumatic drug which progressed to complete a phase III clinical trial, passing all toxicology screens and demonstrating it was suitable for oral use, however the development was halted at this stage due to a lack of efficacy. NeuroSolutions has since reprofiled the drug candidate and undertaken extensive pre-clinical tests to demonstrate NSL-043 is potentially effective in the treatment of neuropathic pain prior to commencing the planned phase I clinical trial.

Sigma Aldrich chemists will utilise previously documented process development procedures for the synthesis of NSL-043 and determine the most efficient process for producing sufficient quantities for the commencement of a phase I clinical trial and additional trials planned for 2006.

"We reviewed a number of UK companies because we wanted to make sure we were hands on -- the lead candidate will be manufactured in the UK by Sigma Aldrich," said NeuroDiscovery chairman David McAuliffe.

"We are going to start phase I clinical trials later this year and phase II next year and plan scale up to be completed in the next six to eight weeks. It is a well know synthesis route and there shouldn't be too many complications in production," said McAuliffe.