Breakthroughs in Parkinson’s Management: Key Findings from Neuroderm’s ND0612 Studies

• NeuroDerm’s ND0612 introduces a pioneering approach to Parkinson’s disease management with its self-administered continuous subcutaneous infusion of levodopa/carbidopa. Unlike traditional oral formulations, ND0612 bypasses the gastrointestinal tract, offering increased bioavailability and potentially more reliable relief from motor fluctuations
• By providing a continuous, adjustable dose of levodopa/carbidopa via subcutaneous infusion, ND0612 aims to extend the therapeutic window for Parkinson’s patients. This innovative approach seeks to minimize motor fluctuations and optimize patients’ “ON” time, thereby offering greater daily-life predictability and independence compared to conventional oral treatments

Neuroderm made a significant impact at the 2024 American Academy of Neurology conference by presenting groundbreaking studies focusing on the efficacy and safety of ND0612, a 24-hour subcutaneous levodopa/carbidopa infusion, in patients with Parkinson’s disease (PD) experiencing motor fluctuations. These studies provide valuable insights into the potential of ND0612 to improve symptom management and quality of life for individuals living with PD.

The first study (NCT04006210) evaluated the efficacy and safety of ND0612 across different subgroups of PD patients experiencing motor fluctuations. The results demonstrated a consistent treatment effect of ND0612 in improving “Good On” time without troublesome dyskinesia across various patient demographics and baseline characteristics. This homogeneity of treatment effect highlights the potential of ND0612 to provide meaningful clinical benefit to a broad spectrum of PD patients.

In a separate analysis from multiple studies (NCT02577523 and NCT02726386), the characterization of infusion site reactions (ISRs) associated with ND0612 infusion was explored. While ISRs were commonly reported as treatment-emergent adverse events, the vast majority of events were mild or moderate in severity and resolved with or without treatment. Despite the incidence of ISRs, most patients continued in the trials, underscoring the overall tolerability of ND0612 infusion.

Findings from an open-label study (NCT02726386) examining the long-term efficacy of ND0612 in reducing OFF time in PD patients with motor fluctuations demonstrated that ND0612 treatment resulted in a substantial reduction in OFF time. A significant proportion of patients achieved clinically meaningful improvements over 12 months of follow-up, providing preliminary support for the sustained efficacy of ND0612 in improving motor symptoms and enhancing overall disease management.

Lastly, an investigation into the onset of efficacy with ND0612 infusion in PD patients experiencing motor fluctuations (NCT02577523) revealed that patients experienced significant improvements in motor function as early as Day 3 of treatment initiation. Further enhancements were observed over the course of the study period, highlighting the rapid onset of action of ND0612 infusion and offering a promising option for patients in need of immediate symptom relief.

Collectively, the studies presented by Neuroderm at the AAN conference underscore the potential of ND0612 as a novel therapeutic approach for PD management. With its ability to provide continuous, sustained levodopa delivery and improve motor fluctuations, ND0612 represents a promising advancement in the treatment landscape for Parkinson’s disease. Further research and clinical trials are warranted to validate these findings and establish ND0612 as a valuable option for patients with PD experiencing motor fluctuations.