ABLi Therapeutics’ Risvodetinib Meets Safety and Tolerability Goals in Phase II Parkinson’s Trial

ABLi Therapeutics has reported positive final results from its Phase II 201 Trial evaluating risvodetinib as a monotherapy in untreated Parkinson’s disease (PD). The selective, brain-penetrant c-Abl kinase inhibitor achieved its primary endpoint of safety and tolerability, showing an adverse event profile comparable to placebo. Findings were presented at the 2025 Movement Disorders Society Annual Congress.

The 12-week study enrolled 126 participants randomised to receive placebo or risvodetinib (50mg, 100mg, or 200mg once daily). Ninety-five percent of subjects completed the trial with 99% dosing compliance. Common side effects such as oedema, nausea, diarrhoea, and cardiovascular events occurred at similar rates to placebo.

Secondary measures of daily living and motor function, including MDS-UPDRS Parts I–II and SEADL scales, showed improvements—some reaching nominal statistical significance. Importantly, risvodetinib also demonstrated potential to reduce alpha-synuclein pathology, a key driver of PD.

15-10-2025