In a significant advancement for Parkinson's disease (PD) treatment, NeuroDerm Ltd., a subsidiary of Mitsubishi Tanabe Pharma Corporation, has unveiled the results of the Phase 3 BouNDless trial, published in The Lancet Neurology.
The study evaluated the efficacy, safety, and tolerability of ND0612, a continuous subcutaneous infusion of levodopa/carbidopa (LD/CD), showing it to be superior to oral immediate-release LD/CD in managing motor fluctuations in PD patients.
Transforming Parkinson's Disease Management
Parkinson's disease, affecting over 10 million people globally, is characterized by the death of dopamine-producing cells in the brain, leading to motor symptoms that severely impact daily living.
Levodopa, combined with a levodopa degradation inhibitor like carbidopa, remains the cornerstone of PD treatment. However, the effectiveness of oral levodopa can wane over time, causing motor fluctuations that are challenging to manage with current therapies.
The BouNDless trial's results offer hope, demonstrating that ND0612 significantly increases "ON" time without troublesome dyskinesia and reduces "OFF" time compared to oral LD/CD.
"This could represent a paradigm shift in how we manage Parkinson's disease, particularly for those experiencing motor fluctuations with current oral therapies," said Professor Alberto Espay, the trial's Principal U.S. Investigator.
Study Highlights
ND0612 achieved a statistically significant increase of 1.72 hours in "ON" time without troublesome dyskinesia over oral LD/CD, meeting the trial's primary endpoint.
Significant reductions in daily "OFF" time were observed, with ND0612 showing an additional 1.4-hour reduction compared to oral LD/CD.
Secondary endpoints, including improvements in the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II scores and both patient and clinician global impressions of change, underscored ND0612's potential to enhance quality of life for PD patients.
The trial's safety profile for ND0612 was consistent with the known safety profile of oral LD/CD, with infusion site reactions being the most reported treatment-emergent adverse events. Notably, dyskinesia, falls, and ON/OFF phenomena were less frequently reported in the ND0612 group.
Looking Forward
With these promising results, ND0612 stands on the cusp of offering a new, less invasive treatment option for PD patients grappling with motor fluctuations.
"These findings not only highlight ND0612's favorable benefit-risk profile but also its potential to significantly improve daily living for this patient population," remarked Tami Yardeni, EVP of Clinical Development at NeuroDerm.
As the medical community eagerly awaits the U.S. Food and Drug Administration's decision, with a target action date set for the second quarter of 2024, the future looks brighter for those battling Parkinson's disease. This breakthrough could herald a new era in PD treatment, emphasizing continuous innovation and patient-centered care in the fight against this challenging condition.
