Evaluate the onset of efficacy for continuous 24-hour subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) with investigational ND0612.

Primary results from this Phase 2 study (NCT02577523) demonstrated that 28 days of treatment with 24-hour ND0612 infusion increased ON-time with no/mild dyskinesia (Good ON) by 3.7 [1.9, 5.6] hours (p < 0.0001) in patients with PD experiencing motor fluctuations (Olanow et al., J Parkinsons Dis 2021;11:177-186). However, less is known about the onset of efficacy following subcutaneous LD/CD infusion.

We report data from a secondary analysis of patients treated with the 24-hour ND0612 infusion regimen (N=19). Patients received the infusion at a rate of 0.64 mL/hour from 4AM to 10PM and 0.08 mL/hour between 10PM and 4AM to a total LD/CD dose of 720/90 mg. Motor status was determined by a blinded-rater at 30-minute intervals for 8 hours. Patients also assessed the time to full ON each morning in a diary. The first post-baseline efficacy evaluations were performed at Day 3.

At Day 3, patients treated with 24-hour ND0612 infusion showed a significant increase from baseline in Good ON-time (+1.83 [0.30, 3.35] hours, p=0.02), and a significant reduction in ON-time with moderate-severe dyskinesia (-1.36 [-2.29, -0.42] hours, p=0.006). Improvements at Day 3 were also noticeable in the Subject and Clinician Global Impressions of change (SGI and CGI improvements were reported for 73.7% and 52.6% of patients, respectively). By the end of the first week of treatment, the proportion of patients who reported achieving a full ON at 9AM increased from 31.6% at baseline to 72.2%.

Results of this analysis demonstrate that patients experience statistically significant and clinically relevant improvements with 24-hour subcutaneous infusion with ND0612 at Day 3 after treatment initiation that improved further to Day 28 (primary endpoint).