Long-term safety of ND0612 in idiopathic PD

ND0612 is a levodopa/carbidopa (LD/CD) solution continuously infused subcutaneously via a pump system. In the phase 2b BeyoND study, long-term safety was established in Parkinson’s disease (PD) patients with motor fluctuations [1]. ND0612 was generally well tolerated with no new safety concerns emerging.

Continuous subcutaneous treatment with ND0612 may be more effective in managing motor fluctuations and other symptoms of PD than oral LD/CD, which often becomes less effective as the disease progresses.

The BeyoND study was an open-label, 1-year safety study in PD patients >30 years who were taking ≥4 levodopa doses/day and ≥1 other PD medications. To be included, patients were required to have ≥2 hours of OFF time per day with predictable early-morning OFF periods. Participants received open-label ND0612 for either 16 or 24 hours. They took adjunct oral PD medications as needed. Mean time since PD diagnosis was 9.0±4.7 years, the mean duration of motor fluctuations was 5.3±4.2 years. Of the 214 PD patients enrolled, 124 were appointed to the 16-hour regimen, while 90 received the 24-hour regimen.

ND0612 was generally well tolerated. Local infusion-site reactions were transient and manageable. Reported systemic treatment-emergent adverse events (AEs) were consistent with those expected for levodopa. The most common treatment-emergent AEs were nodules, haematoma, and pain at the infusion site. Overall, less than a quarter of patients discontinued the study due to treatment-emergent AEs, and serious treatment-related AEs were rare. After 12 months, patients could continue treatment with ND0612; some of them are now in their fourth year. Of these participants, additional data is collected in the study extension.

1. Isaacson S, et al. Abstract O3011, EAN 2020.

 



Posted on 9 September, 202028 March, 2024