Mitsubishi Tanabe Pharma America to Highlight Data on Investigational ND0612 at the 2024 International Congress of Parkinson's Disease and Movement Disorders

JERSEY CITY, N.J., Sept. 27, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced seven presentations on investigational ND0612 in Parkinson's disease (PD) will be shared at the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS), being held September 27-October 1 in Philadelphia, Pa. ND0612 is being evaluated as a continuous, 24 hours/day subcutaneous infusion of liquid levodopa/carbidopa.

"We're looking forward to showcasing an exciting array of Parkinson's disease research from our Phase 2 and 3 studies at MDS, including one-year outcomes from the open-label extension period of our pivotal Phase 3 BouNDless trial, whose 12-week results were published earlier this year," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "These data presentations reinforce our dedication to the ongoing evaluation of investigational ND0612 and commitment to learning more about Parkinson's disease that nearly one-million people are living with in the U.S."¹

MTPA's posters will be presented in Exhibit Hall A on September 29, 1:00-3:00 p.m. ET:

Presentation Details:

Presentations include a range of data from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating ND0612 in people with PD experiencing motor fluctuations, utilizing data derived from patient-reported outcomes assessing quality of life and motor experiences of daily living, among other findings. Additionally, one-year outcomes from the ongoing open-label extension phase of the BouNDless trial will be presented.

• Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized, Active-Controlled Study
  Abstract #: 648
   
• Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Signs of PD and Experiences of Daily Living
  Abstract #: 685
   
• Impact of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor State Transitions Throughout the Day
  Abstract #: 683
   
• Subgroup Analyses of a Phase 3, Randomized Study of Levodopa/Carbidopa Infusion (ND0612) for Parkinson's Patients
  Abstract #: 666
   
• Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) for Motor Fluctuations in Parkinson's Disease
  Abstract #: 653

Additional presentations will highlight findings from analyses of Phase 2 and Phase 3 studies evaluating treatment outcomes from a 24-hour regimen of ND0612, including the characterization of infusion site reactions in patients reported as adverse events (AEs) and the characterization of dopaminergic treatment-emergent AEs reported in patients.

• Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612
  Abstract #: 665
   
• Dopaminergic Adverse Events With 24-hour Subcutaneous Infusion of ND0612
  Abstract #: 684

MTPA will also host an educational disease awareness discussion on PD during the Corporate Therapeutic Symposium on September 29, 1:00-2:00 p.m. ET.

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).

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 National Institute of Neurological Disorders and Stroke. Parkinson's Disease: Challenges, Progress and Promise. https://www.ninds.nih.gov/current-research/focus-disorders/parkinsons-disease-research/parkinsons-disease-challenges-progress-and-promise#:~:text=Approximately%20500%2C000%20Americans%20are%20diagnosed,1%20million%20Americans%20have%20PD. Accessed August 2024.

SOURCE Mitsubishi Tanabe Pharma America