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A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients With Mild to Moderate Parkinson's Disease on Stable Symptomatic Parkinson's Disease Medication and in Patients With Multiple System Atrophy

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Trial Profile

A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients With Mild to Moderate Parkinson's Disease on Stable Symptomatic Parkinson's Disease Medication and in Patients With Multiple System Atrophy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Jun 2025

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At a glance

  • Drugs Exidavnemab (Primary)
  • Indications Parkinson's disease
  • Focus Therapeutic Use
  • Acronyms EXIST

Most Recent Events

  • 13 Jun 2025 According to a BioArctic media release, based on positive safety reviews, the company will initiate two further cohorts, to evaluate a higher dose of exidavnemab in comparison with placebo in patients with Parkinson's disease as well as MSA.
  • 08 May 2025 According to a BioArctic media release, planned number of patients changed from 24 to 36.
  • 08 May 2025 According to a BioArctic media release, regulatory authorities in Spain in Poland have approved the substantial protocol modification of the inclusion of an additional cohort of Multiple System Atrophy (MSA) patients for treatment with the alpha-synuclein antibody exidavnemab in this trial. An additional 12 participants with MSA will be recruited. In addition to the primary endpoints of safety and tolerability, many biomarkers will be evaluated, in plasma and CSF.

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