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

Pivotal Phase 3 data, published in The Lancet Neurology, showed favorable efficacy of ND0612 compared to oral immediate-release levodopa/carbidopa  

JERSEY CITY, N.J., March 18, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of results in The Lancet Neurology from the pivotal, Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy, safety and tolerability of investigational ND0612 ? a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) ? in comparison to oral immediate-release (IR) LD/CD in people with Parkinson's disease (PD) experiencing motor fluctuations. Results from the study, which met its primary endpoint and the first four secondary endpoints, showed ND0612 was superior at increasing "ON" time without troublesome dyskinesia and reducing "OFF" time, compared to oral IR-LD/CD after 12 weeks.

"Orally administered levodopa/carbidopa tablets remain the most essential pharmacological intervention in Parkinson's disease; however, over time, the reliability of its benefits can decrease, leading to the onset of motor fluctuations," said Professor Alberto Espay, Principal U.S. Investigator of the BouNDless trial and Director of the James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders at the University of Cincinnati. "We are encouraged by these positive data, which we believe support ND0612, if approved, as a potential treatment option for people with Parkinson's disease experiencing motor fluctuations who have thus far had limited options."

Study participants entered an open label IR-LD/CD optimization phase followed by an open label ND0612 plus IR-LD/CD optimization phase and were then randomized to a 12-week double-blind double-dummy (DBDD) treatment period with either ND0612 or oral IR-LD/CD regimens. Key study findings include:

• Treatment with ND0612 demonstrated favorable efficacy with a statistically significant addition (p<0.0001) of 1.72 hours in "ON" time without troublesome dyskinesia over oral IR-LD/CD, thus meeting the trial's primary endpoint.
• The trial also demonstrated positive and clinically meaningful results for the first four secondary endpoints, including the key secondary endpoint with an additional 1.4-hour reduction in daily "OFF" time (p<0.0001) with ND0612 vs. oral IR-LD/CD.
• The remaining secondary endpoints that reached statistical significance were the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II scores (-3.05 [-4.28, -1.81], p<0.0001), the Patients Global Impression of Change (Odds Ratio [OR]: 5.31 [2.67, 10.58], p<0.0001) and Clinician Global Impression of Improvement (OR: 7.23 [3.57, 14.64], 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 (ISRs) 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 ISRs (infusion site nodule, infusion site bruising, infusion site infection, infusion site erythema, infusion site pain, infusion site eschar and infusion site swelling) were more frequent in the ND0612 group compared to placebo and oral LD/CD groups. Additionally, only 6% of study participants discontinued the trial during the DBDD period due to any reason ? including 5% due to AEs ? compared to discontinuation rates of 6% and 3%, respectively, of study participants in the oral LD/CD groups.

"These findings from the BouNDless study show us that continuous, subcutaneous delivery of levodopa/carbidopa with ND0612 has the potential to impact people living with Parkinson's disease who experience motor fluctuations," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We look forward to the continued evaluation of ND0612 to further our understanding of its effect in Parkinson's disease, and as a part of our commitment to address unmet needs for this patient population."

Analyses of results from the ongoing BouNDless trial complement the long-term safety data from the BeyoND study (NCT02726386) assessing ND0612, with some patients in their eighth year of follow-up.¹

About ND0612
ND0612 is an investigational drug-device combination therapy ? a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). The safety and efficacy of ND0612 in PD is under review by the U.S. Food and Drug Administration (FDA), who has assigned a Prescription Drug User Fee Act (PDUFA) target action date for the second quarter of CY (calendar year) 2024.

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.

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¹ S 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.

SOURCE Mitsubishi Tanabe Pharma America