Presenter of 1 Presentation
RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AKST4290 IN PARKINSON’S DISEASE
Abstract
Aims
Development of novel therapeutic strategies in Parkinson’s disease (PD) is needed to treat the unmet needs of patients. Eotaxin and C-C motif chemokine receptor 3 (CCR3) are associated with neuroinflammatory processes. AKST4290, a small molecule CCR3 antagonist, demonstrated beneficial effects on motor function, microgliosis, and immune cell infiltration in preclinical models of PD. A clinical trial was conducted to evaluate the safety and therapeutic potential of AKST4290 in PD.
Methods
Patients were randomized 1:1 to AKST4290 (400 mg twice daily) or placebo for 12 weeks. The primary endpoint was the change from baseline in motor function during the off-medication state at 12 weeks as measured by the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 3. Secondary endpoints included assessment of safety/tolerability and changes in clinical function, motor function, and activities of daily living during the on-medication state, as well as cognitive, psychological, and motor assessments using validated tools.
Results
A total of 110 patients were randomized to AKST4290 or placebo, and 93 completed the study. Safety and tolerability were favorable, with adverse events similar across groups. Subjects on both AKST4290 and placebo improved at a similar magnitude for the MDS-UPDRS Part 3. AKST4290 demonstrated improvement over placebo in the MDS-UPDRS Part 2, Parkinson’s Disease Questionnaire-39 (PDQ-39), and Clinical Impression of Severity Index-PD (CISI-PD).
Conclusions
Improvements with AKST4290 treatment were evident in select important assessments of relevance to PD patients. The results of this study support continued investigation of AKST4290 in neuroinflammation in PD.