Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of positive results from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial of investigational ND0612.
| ND0612 demonstrated favorable efficacy compared to oral standard of care levodopa/carbidopa (LD/CD) and systemic safety profile was consistent with well-established safety profile of oral LD/CD JERSEY CITY, N.J., Aug. 29, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of positive results from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) – as part of the International Congress of Parkinson’s Disease and Movement Disorder Society (MDS), being held in Copenhagen, Denmark, August 27-31. The study, which evaluated the efficacy, safety and tolerability of ND0612 in comparison to oral immediate-release (IR) LD/CD in people with Parkinson’s disease (PD) experiencing motor fluctuations, met its primary endpoint and the first four secondary endpoints. Results, which follow positive topline data reported earlier this year, will be presented as both a poster and part of an Oral Platform Presentation at the meeting.
“We are thrilled to present these positive results from our ongoing Phase 3 BouNDless trial, as they help us further understand the effect of ND0612 in people with Parkinson’s disease experiencing motor fluctuations,” said Yasutoshi Kawakami, President of MTPA. “The outcome of this trial exemplifies our commitment to continue recognizing the unmet needs of people living with this disease, and we look forward to sharing additional study findings with the scientific community.” Following two sequential open-label periods to optimize oral IR-LD/CD and ND0612, study participants were randomized to a 12-week DBDD treatment period with either ND0612 or oral IR-LD/CD. Treatment with ND0612 demonstrated favorable efficacy over IR-LD/CD with a statistically significant increase (p<0.0001) of 1.72 hours in “ON” time without troublesome dyskinesia. The trial also demonstrated positive and clinically meaningful results for the first four secondary endpoints, including reduction of “OFF” time (p<0.0001). Additional secondary endpoints that reached statistical significance were the MDS-Unified Parkinson’s Disease Rating Scale Part II score (MDS-UPDRS motor experiences of daily living sub-score) (p<0.0001), the Patient Global Impression of Change (PGIC) (p<0.0001) and the Clinical Global Impression of Improvement (CGI-I) (p<0.0001). The systemic safety profile of ND0612 was consistent with the well-established safety profile of oral standard of care LD/CD. Infusion site reactions were the most reported treatment emergent adverse events (TEAEs) in any group during the DBDD period (57% for ND0612 vs. 43% for IR-LD/CD). Some infusion site reactions (hematoma, infection, erythema, pain, infusion eschar) were more frequent in the ND0612 group compared to oral LD/CD. Additionally, only 6.3% of study participants discontinued the trial during the DBDD period due to any reason – including 5.5% due to AEs – compared to discontinuation rates of 6.1% and 3.1%, respectively, of study participants in the oral LD/CD groups. Analyses of results from the ongoing BouNDless trial complement the long-term safety data assessing ND0612 with up to seven years of follow-up.1 Additional data will be communicated at a future date. About ND0612 About Mitsubishi Tanabe Pharma America, Inc. About Mitsubishi Tanabe Pharma Corporation About NeuroDerm, Ltd. 1S Isaacson, et al. Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study. Poster presented at: American Academy of Neurology Annual Meeting; 2022 Apr 2-7; Seattle, WA. Media inquiries:
SOURCE Mitsubishi Tanabe Pharma America, Inc. |
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