To evalute the safety, tolerability and clinical benefit of risvodetinib (IkT-148009) in untreated Parkinson's disease.

Risvodetinib was given once daily at 50, 100 or 200 mg, all believed to be therapeutic doses. 120 patients were randomized 1:1:1:1 across the three doses or placebo for 12 weeks and subsequently rolled into a 12 month extension study with the placebo group moving onto the top therapeutic dose. Safety and tolerability were measured by evaluation of frequency and severity of treatment-emergent adverse events, measures of cardiovascular safety, standard laboratory analyses and monitoring for changes in vision. A hierarchy of 15 secondary endpoints evaluated the potential benefit of risvodetinib on measures of motor and non-motor function in the Central and Enteric Nervous Systems. Biomarker analysis using CSF/plasma assessment by seed-amplification assay and skin biopsy complement functional assessments.

Data from a 12 week double-blinded, placebo controlled trial will be presented providing a first look into whether a treatment validated in models of heritable and sporadic PD can impact disease in human Parkinson's.