A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy

Parkinson's disease (PD) is the second most common neurodegenerative condition, withstudies estimating US prevalence among individuals aged 45 years and older rising toapproximately 1,238,000 by 2030. More than 75% of individuals with PD will experienceresting tremor at some point during their disease course, and approximately 60%additionally suffer from a symptomatic tremor during action or movement, complicatingfunctional tasks.The distress caused by PD tremor is profound, with individuals consistently identifyingit as their "most bothersome" symptom in early disease, and more impactful than othermotor and nonmotor symptoms. Despite the clear importance of this symptom to patientexperience, significant unmet need in tremor management persists. Tremor‐specificefficacy of dopaminergic therapy, the mainstay of early PD pharmacology, is ofteninconsistent or incomplete, giving rise to the clinical concept of "dopamine‐responsive"versus "dopamine‐refractory" tremor. Anti‐tremor efficacy of anticholinergic agents hasbeen recognized for decades; however, their clinical utility is limited by both centraland peripheral adverse effects VIM0423 is being developed as an oral medication designedto improve the central and peripheral tolerability seen with other anticholinergicmedications.Vista PD (Study VIM0423‐251) is a Phase 2, multicenter study designed to assess theefficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's diseasetremor insufficiently responsive to dopaminergic therapy. Up to 80 individuals will beenrolled in the trial.Cohort 1 will be comprised of adults diagnosed with PD who are on stable and adequatedopaminergic therapy (oral levodopa or oral dopamine agonist only), with residual tremor.Participants in Cohort 1 will be randomized (1:1) to receive either VIM0423 or matchingplacebo (up to 5 pills a day[MO1.1][TG1.2][MO1.3], taken once daily) for 7 weeks. TheInvestigator and Participant will not know whether [MO2.1]patients are receiving VIM0423or placebo, but that information will be available if needed.Cohort 2 will be comprised of adults diagnosed with PD who are dopaminergic naïve, asdefined by: no prior or ongoing usage of levodopa (in any form) or dopamine agonist (inany form), and no anticipated plans to initiate said therapies for the duration of thestudy. Participants in Cohort 2 will be randomized (1:1) to receive either VIM0423 ormatching placebo (up to 5 pills a day[MO3.1], taken once daily) for 7 weeks. TheInvestigator and Participant will not know whether patients are receiving VIM0423 orplacebo, but that information will be available if needed.The total time of participation in the trial is up to 12 weeks and requires 6 in personvisits. The study schedule includes Screening and Baseline (up to 4 weeks, 2 visits),Treatment period (including taper, 7 weeks, 3 Visits), and Safety follow‐up (1 week, 1Visit).Assessments of changes in Parkinson's disease will be made by study personnel. Clinicallabs, EKGs, and Adverse events will be monitored throughout the study. Participants willbe asked to use a wearable device during the study and perform self‐assessments of theirParkinson's tremor and its impact on their activities of daily living.