JERSEY CITY, N.J. February 6, 2025 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of three-year outcomes in Parkinsonism and Related Disorders from the extension phase of the ongoing Phase 2b BeyoND long-term safety and tolerability study (NCT02726386) evaluating investigational ND0612 in people with Parkinson’s disease (PD) experiencing motor fluctuations. ND0612 is being studied as a 24-hour, continuous, subcutaneous infusion of liquid levodopa/carbidopa (LD/CD).
The three-year results from the extension phase of BeyoND were found to be consistent with the previously-reported 12-month data from the core study period, suggesting treatment with ND0612 to be generally well tolerated. Additionally, exploratory data from a small sample size of participants with available motor diary data indicate the potential of ND0612 to provide a sustained reduction in daily OFF time with a corresponding increase in Good ON time.
“As Parkinson’s disease advances and oral treatment options are no longer able to provide adequate symptom management, motor fluctuations can become increasingly debilitating and challenging to manage for patients,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “The three-year BeyoND data, which confirm the positive one-year safety outcomes, are encouraging as we continue to study ND0612 for this patient population in need of alternate treatments for long-term symptom management.”
During the extension phase, no unexpected treatment-emergent adverse events were revealed with long-term treatment and the systemic safety profile of ND0612 remained as expected for a LD/CD product. While participants experienced injection site reactions throughout the extension phase, they were reported as generally mild and rarely led to discontinuation.
The detailed results can be found in the journal publication, linked here.
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, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. 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 by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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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