Objective: To review one-year exploratory efficacy data from the ND0612 BeyoND study.

Background: ND0612 is an investigational subcutaneous delivery system providing minimally invasive, continuous infusion of liquid levodopa/carbidopa.  Prior Phase II studies have shown that ND0612 reduced OFF-time and increased ON-time with no or mild dyskinesia, in patients with PD and motor fluctuations.

Method: The BeyoND study is an ongoing international, open-label Phase 2b study (NCT02726386) evaluating the long-term safety of two ND0612 dosing regimens in PD patients with Hoehn & Yahr score of ≤3 during ON experiencing ≥2 hours daily OFF-time. Exploratory efficacy measures included ‘good’ ON-time (ON without dyskinesia + ON with non-troublesome dyskinesia) and OFF-time normalized to 16 waking hours as determined from ON/OFF home diary entries as well as UPDRS (activities of daily living [ADL] and motor) scores. Least square (LS) mean changes from baseline were analyzed using Mixed Model Repeated Measures.

Results: Good ON-time increased by an adjusted mean of 2.3 hours at Month 3 in the 24-hour dosing regimen (n=44) and 2.6 hours in the 16-hour dosing regimen (n=83), and improvement was maintained over 12 months. OFF-time decreased by an adjusted mean of -2.3 hours at Month 3 in the 24-hour regimen and 2.4 hours in the 16-hour regimen, with such reductions also sustained over 12 months. ON-state UPDRS-motor scores improved within the first month in both groups and this was maintained through month 12  (LS mean [95%CI] change from baseline of -6.62 [-8.56, -4.67]  at Month 1 (n=76) & -6.09 [-8.61, -3.57] at Month 12 (n=51) in the 24h regimen and -6.61 [-8.30, -4.91] at Month 1 (n=99) & -5.12 [-7.37, -2.87] at Month 12 (n=64) in the 16-hour regimen). UPDRS ADL scores also improved (change from baseline of -3.06 [-3.92, -2.20] at Month 1 & -2.47 [-3.75, -1.19] at Month 12 in the 24-hour regimen and -3.68 [-4.43, -2.93] at Month 1 & -2.49 [-3.62, -1.36] at Month 12 in the 16-hour regimen.

Conclusion: This open-label, nonrandomized study provides preliminary support for the 12-month efficacy of treatment with ND0612 in increasing ‘good’ ON-time and ADL as well as reducing OFF-time and motor disability in patients with PD and motor fluctuations.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/subcutaneous-levodopa-infusion-for-parkinsons-disease-patients-with-motor-fluctuations-open-label-efficacy-outcomes-from-the-beyond-study/