Category: Parkinson’s Disease: Clinical Trials
Objective: Assessment of efficacy and safety in subjects with Parkinson’s disease (PD) following treatment for 12 weeks with placebo or AKST4290, a highly specific and potent small molecule antagonist of CCR3.
Background: Development of novel therapeutic strategies in PD remains a major unmet need.
[SM1] CCR3 is a chemokine receptor that may modulate immune and inflammatory processes in the pathogenesis of Parkinson’s disease. AKST4290 demonstrated beneficial effects on motor function, microgliosis, and immune cell infiltration in mouse models of PD. The anti-neuroinflammatory effects were observed as early as 3 days after start of treatment, and motor improvement was observed within 3-5 weeks.
Method: Approximately 120 men and women (50-80 years) with PD on stable L-DOPA treatment, with a Hoehn and Yahr </=2.5 and with notable motor worsening during the off-medication state, will be randomly allocated (1:1) to AKST4290 or placebo for 12 weeks. The study includes seven in-clinic visits: screening visit, baseline visit, treatment visits (x4), and a follow-up visit. Motor, functional, and other efficacy assessments, as well as safety and tolerability assessments, will be performed at select timepoints.
Results: The primary endpoint is the change from baseline in motor function during the off-medication state at 12 weeks as measured by the Movement Disorder Society’s Unified Parkinson’s Disease Rating ScalePart 3. Secondary endpoints include assessment of safety/tolerability and changes in clinical function, motor function, and activities of daily living during the on-medication state using validated scales. Exploratory endpoints include motor assessments via a wearable device, pharmacogenomics/biomarkers, and, in consenting subjects, changes in gut microbiome markers. Subject demographics and enrollment characteristics will be presented.
Conclusion: The current study is ongoing. AKST4290 has the potential to provide an alternative treatment option for patients with PD. TEAL will be the first Phase II randomized study to establish efficacy and safety of AKST4290 in PD.
To cite this abstract in AMA style:E. Rawner, J. Powell, S. Minami, K. Tang, V. Klutzaritz, E. McCaskill Newman, J. Hannestad. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson’s Disease on Stable Dopaminergic Treatment (TEAL Study) [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-study-to-evaluate-the-efficacy-and-safety-of-akst4290-in-subjects-with-parkinsons-disease-on-stable-dopaminergic-treatment-teal-study/. Accessed December 5, 2023.
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