Objective: To evaluate three-year outcomes from the ND0612 BeyoND study.

Background: Investigational ND0612 is in development as a 24-hour continuous, subcutaneous infusion of liquid levodopa/carbidopa for people with Parkinson’s disease (PwP) experiencing OFF time. One year data from the BeyoND study showed that ND0612 was generally safe and well-tolerated and provided a sustained ≥2-hour increase in daily ON-time without troublesome dyskinesia with a corresponding reduction in OFF-time compared to baseline [1].

Method: The BeyoND study is an ongoing international, open-label study (NCT02726386) evaluating the long-term safety of ND0612 in PwP experiencing ≥2 hours daily OFF-time. We report here data for the subgroup of patients who completed the first year of treatment (primary endpoint) and entered the open-label extension (OLE) phase.

Results: Of the 114 patients who continued into the OLE, 94 (82.5%) completed ≥2 years and 76 (66.7%) completed ≥3 years of ND0612 treatment. The main reasons for discontinuation were withdrawal of consent (n=8 in Year 2 and n=5 in Year 3) and adverse events (AEs) (n=4 in Year 2 and n=10 in Year 3). Treatment-related AEs were reported by 73.7% of OLE patients in Year 1, decreasing to 36.9% in Year 2 and 39.4% in Year 3. While 54.7% patients experienced infusion-site reactions (ISRs), these led to early discontinuation in 4.4% of OLE patients. The incidence of infusion-site infection decreased from 19.3% in year 1 to 9.9% in Year 2, and 11.7% in Year 3, while incidence of other ISRs decreased from 60.5% in Year 1 to 26.1% in Year 2, and 27.7% in Year 3. Dyskinesia was reported in 3.5% of OLE patients in Year 1, 0% in Year 2, and 1.1% in Year 3. At Month 36, the mean reduction in OFF-time vs baseline was -2.81 hours and the increase in Good ON-time was 2.79 hours compared to baseline.

Conclusion: Three-year data from the open-label extension study support the long-term safety, tolerability, and efficacy of ND0612.

References: [1] Poewe W, Stocchi F, Arkadir D, et al. Subcutaneous Levodopa Infusion for Parkinson’s disease: One-Year Data from the Open-Label BeyoND study. Mov Disord 2021; 36(11):2687-2692.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/continuous-subcutaneous-levodopa-carbidopa-infusion-with-nd0612-for-parkinsons-disease-three-year-data-from-the-open-label-beyond-study/