Mitsubishi Tanabe Pharma America Presents Positive Results from Pivotal Phase 3 BouNDless Trial of Investigational ND0612 in People with Parkinson's Disease Experiencing Motor Fluctuations

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
ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations. Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). If regulatory approval for ND0612 is obtained, Mitsubishi Tanabe Pharma America, Inc. (MTPA), intends to commercialize the therapy in the U.S.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly, Twitter), Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.

About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at www.neuroderm.com or follow the Company on LinkedIn.

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.

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SOURCE Mitsubishi Tanabe Pharma America, Inc.