JERSEY CITY, N.J. August 28, 2023 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that four presentations in Parkinson’s disease (PD) will be shared at the International Congress of Parkinson’s Disease and Movement Disorder Society (MDS), being held in Copenhagen, Denmark, August 27-31.
“We’re eager to share our latest data for investigational ND0612 in Parkinson’s disease, including the results from the pivotal Phase 3 BouNDless study following positive topline data from earlier this year, and findings from a responder-analysis of the Phase 2b BeyoND long-term safety study,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “Our presence at MDS, where we have the opportunity to continue sharing our progress with the scientific community, reflects our commitment and ongoing efforts to find ways to tackle debilitating conditions like Parkinson’s disease.”
All posters will be showcased in the Poster and Exhibit Hall (Hall C). Specific timing is noted below.
Presentation Details:
Presentations include results from the ongoing pivotal Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless study evaluating the efficacy, safety and tolerability of investigational ND0612 in people with PD experiencing motor fluctuations, in addition to findings of a responder-analysis from the Phase 2b BeyoND long-term safety study assessing the efficacy of ND0612 in reducing OFF time in people with PD with motor fluctuations. Results from the BouNDless study, 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. Additional presentations will highlight three-year safety and efficacy outcomes from the BeyoND long-term safety study, and the development of a Motor Fluctuations Patient Journey Map for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care.
- Continuous subcutaneous levodopa/carbidopa infusion with ND0612 for patients with Parkinson’s disease and motor fluctuations: Results from the Phase 3 randomized, active-controlled BouNDless study
Abstract #11: 1:00 p.m. – 3:00 p.m. CEST, August 28- Oral Platform Presentation Group 5: Clinical Trials (1:45 p.m. – 2:45 p.m. CEST, August 29; Olivier Rascol M.D., Ph.D.; University of Toulouse)
- Reductions in OFF time with ND0612 for patients with Parkinson’s disease experiencing motor fluctuations: Responder-analysis from an open-label Phase 2 study
Abstract #46: 1:00 p.m. – 3:00 p.m. CEST, August 28
- Continuous subcutaneous levodopa/carbidopa infusion with ND0612 for PD: 3-year data from the open-label BeyoND study
Abstract #108: 1:00 p.m. – 3:00 p.m. CEST, August 28
- Motor Fluctuations Patient Journey: Development of a patient journey map for people living with PD
Abstract #1302: 1:00 p.m. – 3:00 p.m. CEST, August 29
This press release is intended for U.S. audiences only.
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 (formally, 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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