Evaluate three-year outcomes from the ND0612 BeyoND study. 

ND0612 is in development as a continuous, subcutaneous levodopa/carbidopa delivery system for PD patients experiencing motor fluctuations. One year data showed that ND0612 was safe and well-tolerated and provided a sustained ≥2-hour improvement in daily ‘Good’ ON-time without troublesome dyskinesia and a corresponding reduction in OFF-time through 12 months of treatment. 

The BeyoND study is an ongoing international, open-label study (NCT02726386) evaluating the long-term safety of ND0612 in PD patients experiencing ≥2 hours daily OFF-time. The primary endpoint was assessed at 12 months followed by an extension (OLE) of up to 108 months. 

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; main reasons for discontinuation were withdrawal of consent in the 2^nd (n=8) and 3^rd (n=5) years, and adverse events (AEs) (n=4 and n=10, respectively). Of those patients who started the OLE, treatment-related AEs were reported by 73.7% of patients in Yr1, decreasing to 36.9% in Yr2 and 39.4% in Yr3. While most patients experienced infusion-site reactions (ISRs), these led to early discontinuation in only 4.4% of patients. The incidence of infusion-site infection decreased from 19.3% in Yr1 to 9.9% in Yr2, and 11.7% in Yr3, while incidence of other ISRs decreased from 60.5% in Y1 to 26.1% in Yr2, and 27.7% in Yr3. Dyskinesia was reported in 3.5% of patients in Yr1, none in Yr2, and 1.1% in Yr3. At Month 36, the mean reduction in OFF-time was -2.81h and the increase in Good ON-time was 2.79h. 

Three-year data from this open-label study support the long-term safety, tolerability, and efficacy of ND0612. For patients who entered the OLE, the high rate of retention supports a favorable benefit-risk ratio of ND0612.