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- NeuroDerm Announces Publication of Positive Results from Phase 3 BouNDless Trial Evaluating ND0612 in Parkinson's Disease Patients with Motor Fluctuations
REHOVOT, Israel, March 18, 2024 /PRNewswire/ -- NeuroDerm Ltd., a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), today announced the publication of results in The Lancet Neurology from the pivotal Phase 3 BouNDless trial ( NCT04006210).
Results of the trial, which evaluated the efficacy, safety, and tolerability of investigational ND0612, a continuous subcutaneous (SC) injection of levodopa/liquid carbidopa (LD/CD), 24 hours/day, compared to immediate-release oral administration (IR) LD/CD in Parkinson's disease (PD) patients with motor fluctuations, met its primary endpoint and first four secondary endpoints, and demonstrated that ND0612 was superior with increasing "ON" time without dyskinesia discomfort and reduce "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 their benefits may decrease, leading to the development of motor fluctuations," said Professor Alberto Espay, principal investigator of the BouNDless trial in the US 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 who experience motor fluctuations and who until now have 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 randomly assigned to a 12-week double-blind (DBDD) treatment period with ND0612 or oral IR-LD/CD regimens. Key findings of the study include:
"Motor fluctuations are a very common symptom associated with the use of oral LD/CD in Parkinson's disease, and often cause significant disruptions in daily life as the disease progresses," said Tami Yardeni, executive vice president of Clinical Development. , NeuroDerm. "We now have compelling evidence supporting the favorable benefit-risk profile of ND0612. These results show significant improvement in motor fluctuations as well as improvements in daily living experiences for this challenging patient population."
Analyzes of results from the ongoing BouNDless trial complement long-term safety data from the BeyoND study (NCT02726386), which includes patients in their eighth year of follow-up.1
About Parkinson's disease Parkinson's disease affects more than 10 million people worldwide. It is caused by decreased dopamine signaling in the brain as dopaminergic brain cells die. Levodopa is the most important replacement therapy for Parkinson's disease and is given together with an inhibitor of levodopa breakdown (usually carbidopa). Oral ingestion of levodopa produces fluctuating plasma concentrations, with high peaks and low troughs that contribute to the progressive appearance of disabling clinical oscillations throughout the day in the motor function of many people with Parkinson's disease. With disease progression, adjustments in oral levodopa therapy become increasingly less effective in controlling such motor complications, leaving patients with limited treatment options that are highly invasive.
About ND0612 ND0612 is an investigational drug and device combination therapy: a continuous subcutaneous (SC) infusion of levodopa/liquid carbidopa (LD/CD) 24 hours/day for the treatment of motor fluctuations in people with Parkinson's disease (PD). ). The safety and effectiveness of ND0612 in PD is under review by the US Food and Drug Administration (FDA), which has assigned a target action date for the Prescription Drug User Fee Act ( PDUFA) for the second quarter of 2024.
About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Israel, inspired to reduce the burden of disease and improve the quality of life of patients and their families by through innovative combination drug and device technologies and therapies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates designed to address major shortcomings of current treatments. For additional information, visit NeuroDerm's website at www.neuroderm.com or follow us on LinkedIn.
About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharmaceutical arm of Mitsubishi Chemical Group (MCG), is one of the world's oldest pharmaceutical companies, founded in 1678 and focused on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of the Japanese pharmaceutical industry. MCG has positioned health as a strategic axis of its management policy, "Forging the future." MTPC sets the MISSION to “Create hope for all who face disease”. To this end, MTPC works in the areas of central nervous system diseases, immunoinflammation, diabetes and kidney and cancer. MTPC focuses on "precision medicine" to provide medications with a high level of treatment satisfaction by identifying patient populations with high potential for efficacy and safety. Additionally, MTPC is working to develop “solutions around the pill” to address specific patient concerns based on therapeutic medicine, including disease prevention, pre-symptomatic disease management, aggravation prevention, and prognosis. For more information, please visit https://www.mt-pharma.co.jp/e/.
About Mitsubishi Tanabe Pharma America, Inc. Headquartered in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of the wholly owned U.S. holding company of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to market approved pharmaceutical products in North America. For more information, visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
1S Isaacson, et al. Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study. Poster presentado en: American Academy of Neurology Annual Meeting; 2022 Apr 2-7; Seattle, WA.
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