Clinical Data With Foscarbidopa/Foslevodopa CSCI in Parkinson Disease

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Summary of Phase 3 Clinical Trials for Continuous Subcutaneous Foscarbidopa/Foslevodopa

12-Week Randomized, Double-Blind Trial

Efficacy

• Significant reduction in OFF time compared to placebo (primary end point)
• Meaningful increase in ON time without troublesome dyskinesia
• Improved UPDRS motor scores during ON periods
• Greater proportion of patients achieved ≥1 hour reduction in daily OFF time
• Effects observed as early as week 1 and maintained throughout the trial

Safety

• Most common adverse events: infusion site reactions, nausea, dyskinesia
• Majority of infusion site reactions were mild to moderate in severity
• Low discontinuation rate due to adverse events (~5%)
• No clinically significant changes in laboratory values
• No unexpected safety signals compared to oral levodopa/carbidopa
• No serious device-related complications

Quality of Life

• Significant improvement in PDQ-39 scores (Parkinson’s Disease Questionnaire)
• Enhanced patient-reported daily functioning
• Improved sleep quality measures
• Reduced caregiver burden
• High treatment satisfaction scores

52-Week Open-Label Extension Trial

Efficacy

• Sustained reduction in OFF time throughout the extended treatment period
• Maintained improvement in ON time without troublesome dyskinesia
• Stable UPDRS motor scores, suggesting durable symptomatic control
• Reduced need for rescue medication compared to baseline
• No evidence of tolerance development

Safety

• Consistent safety profile with the 12-week study
• Declining incidence of infusion site reactions over time, suggesting adaptation
• No new safety concerns with prolonged exposure
• Manageable and predictable adverse event profile
• Low rate of serious adverse events related to treatment
• Device-related complications remained infrequent

Quality of Life

• Sustained improvement in PDQ-39 scores through 52 weeks
• Maintained positive impact on activities of daily living
• Persistent improvement in sleep quality
• Stable or improved non-motor symptom scores
• High retention rate, indicating acceptable patient tolerability and satisfaction

Clinical Implications

• Continuous subcutaneous foscarbidopa/foslevodopa provides a viable alternative for advanced Parkinson disease patients with motor fluctuations
• The prodrug formulation allows for stable plasma levodopa levels, potentially addressing the limitations of oral therapy
• Benefits appear durable over the long-term with a manageable safety profile
• May be particularly beneficial for patients with refractory motor fluctuations or those unsuitable for deep brain stimulation