The randomised, double-blind, placebo-controlled safety, tolerability and preliminary efficacy trial evaluated three increasing doses of the compound, versus placebo, in 12 patients with idiopathic PD of moderate severity. The participants administered sNN0031 or placebo for two weeks and then were followed up to 12 weeks for initial analyses.
The findings demonstrated that the drug was well-tolerated with no drop-outs and treatment-related side effects. Dopamine transporter activity, assessed using PET technology, showed a dose-dependent improvement in the substantia nigra and putamen, areas of the brain damaged by PD.
Newron has already commenced regulatory meetings in Europe and the USA, seeking approval to start a proposed Phase II/III pivotal placebo-controlled trial of sNN0031 in severe PD patients who do not benefit from therapy with optimised standard of care.
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