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
18 Mar 2024
Clinical ResultPhase 3
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."
Treatment with ND0612 demonstrated favorable efficacy with a statistically significant addition (p
"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.
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.
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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