Objective: To evaluate the effect on slowing motor progression and the safety of prasinezumab, a humanized monoclonal antibody targeting aggregated alpha-synuclein, in individuals with early Parkinson’s disease (PD) on stable symptomatic therapy.

Background: Results from the double-blind part of the PASADENA Phase II study, multicenter, randomized, placebo-controlled trial evaluating the safety and efficacy of intravenous prasinezumab, administered every 4 weeks, in early-stage PD showed that prasinezumab reduced 1-year motor progression as measured by MDS-UPDRS part III compared to placebo in individuals with early-stage PD.

Method: PADOVA is a Phase IIb, randomized, double blind, placebo-controlled multicenter study. Individuals with early PD will receive monthly intravenous doses of prasinezumab 1,500 mg or placebo for at least 76 weeks, followed by a 2-year extension with all participants on active treatment. Key inclusion criteria are: age 50-85 years; diagnosis of idiopathic PD based on MDS criteria; Hoehn & Yahr (H&Y) Stage I or II; time from diagnosis 3 months to 3 years; DAT-SPECT imaging consistent with PD; and on a stable dose of monoamine oxidase B inhibitor (MAO-Bi) or levodopa.

Results: The PADOVA study enrolled 586 individuals with early-stage PD. Of these, 74.4% were on stable doses of levodopa (n=436) and 25.6 % on MAO-Bi (n=150). The PADOVA study population was slightly more advanced than PASADENA in terms of disease duration (18.6 vs 10.1 mo), H&Y stage (stage II 83.9% vs 75.3%) and MDS-UPDRS part III (24.5 vs 21.5 points).

Conclusion: The PADOVA study population is suitable for investigating the potential of prasinezumab to slow disease progression in individuals with early PD on stable symptomatic therapy.

« Back to 2024 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/a-study-to-evaluate-the-efficacy-and-safety-of-intravenous-prasinezumab-in-participants-with-early-parkinsons-disease-padova-rationale-design-and-baseline-data-2/