ND0612 is a novel liquid formulation of levodopa/carbidopa (LD/CD) for continuous subcutaneous (SC) administration via infusion pump system. ND0612 contains 60 mg/mL LD and 7.5 mg/mL of CD and is being developed for patients with LD-responsive PD who do not have satisfactory control of debilitating motor fluctuations and hyper/dyskinesia despite optimized treatment with commercially available PD oral products, providing a total daily dose of up to 720 mg LD and 90 mg CD over 24 hours.
In a Phase IIa study, ND0612 was shown to reach high levodopa steady plasma levels, indicating that it may provide an effective alternative to current treatments requiring surgery, such as deep brain stimulation and LD/CD Intestinal gel.
In a 28-day randomized, parallel-group, open-label, blinded-rater study, subjects with fluctuating PD were randomized to receive 24 hour or 14-hour infusions of ND0612. Supplemental oral LD/CD was used as needed. The primary endpoint was change from baseline to Day 28 in daily OFF. Key Secondary endpoints included change from baseline in percent of subjects with early morning ON, ON time without troublesome dyskinesa, UPDRS II and III, Clinical Global Impression, Parkinson’s Disease Sleep Scale (PDSS), and the 39-Item PD Quality of Life [QoL] Questionnaire (PDQ-39).
BeyoND (NCT02726386) is an ongoing multi-center, international, open-label, long-term safety study of ND0612 for the management of motor fluctuations in Parkinson’s disease (PD). Adult patients with a diagnosis of PD on LD treatment were eligible for the study if they had more than 2 hours of ‘off-time’ a day. Patients were assigned to open-label treatment with ND0612 for either 24 hours or 16 hours for a total LD/CD daily dose of 720/90mg. Adjunct oral PD medications could be taken as needed. Safety and tolerability were assessed through adverse events and percentage of early treatment discontinuations. At the end of the study, patients can opt to continue their allocated treatment for an additional 5-years.