Mitsubishi Tanabe Pharma America Shares Phase 3 BouNDless Trial Results of ND0612 in Parkinson's Disease

Mitsubishi Tanabe Pharma America, Inc. (MTPA) has recently shared new insights from the Phase 3 BouNDless trial and its open-label extension (OLE), assessing the investigational ND0612 in Parkinson's disease (PD) patients experiencing motor fluctuations. This information was disclosed during the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS). ND0612 is being developed as a 24-hour continuous subcutaneous infusion of levodopa/carbidopa (LD/CD).

The data from the BouNDless-OLE phase reaffirm the long-term efficacy of ND0612, showing consistency with the 12-week findings previously reported. Additionally, patient-reported outcomes illustrate that ND0612 outperforms oral immediate-release (IR) LD/CD in various quality of life (QoL) aspects and motor experiences of daily living (m-EDL).

Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA, highlighted the significance of these results, noting that the long-term efficacy of ND0612 could provide a substantial reduction in symptom burden for Parkinson's patients. This underscores MTPA's commitment to advancing ND0612 as a potential new treatment for motor fluctuations in Parkinson's disease.

Key presentations at the MDS meeting included:

Abstract #653 focused on the long-term efficacy of ND0612. Patients who completed the double-blind double-dummy (DBDD) phase were eligible for the OLE phase. At six months, participants treated with ND0612 saw an average reduction of 2.2 hours in daily OFF time and an increase of 2.4 hours in ON time without troublesome dyskinesia. These benefits were sustained at 12 months, with a 2.02-hour reduction in OFF time and a 2.11-hour increase in ON time without severe dyskinesia. Additionally, participants with over an hour of ON time with troublesome dyskinesia experienced a reduction of 1.5 hours in dyskinesia at 12 months.

Abstract #648 presented findings on QoL improvements with ND0612 assessed using the PD Questionnaire-39 (PDQ-39). After the DBDD period, patients on ND0612 reported a QoL improvement score of -2.1 compared to the IR-LD/CD group, which showed no significant change (+0.6). The ND0612 group saw enhancements in domains such as mobility, bodily discomfort, cognition, activities of daily living, stigma, social support, communication, and emotional well-being.

Abstract #685 examined the efficacy of ND0612 on motor signs and daily living experiences. Results indicated that ND0612 led to better improvements in m-EDL compared to oral IR-LD/CD, as measured by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III. Post-hoc analysis showed ND0612's superiority in addressing motor signs, such as postural instability-gait disorder, speech and oral health, tremor, and self-care, with no significant differences for rigidity and bradykinesia.

ND0612 was generally well tolerated during the trial. Common systemic treatment emergent adverse events (TEAEs) in the open-label run-in period included dyskinesia, ON and OFF phenomenon, and falls. During the maintenance phase, only 2% of patients in both ND0612 and IR-LD/CD groups reported dyskinesia. Additionally, only 6% of participants using ND0612 discontinued the trial during the maintenance phase, including 5% due to adverse events, compared to 6% and 3% in the IR-LD/CD groups.

ND0612 represents a 24-hour continuous subcutaneous infusion of levodopa/carbidopa being developed to manage motor fluctuations in Parkinson's patients. Its development is led by NeuroDerm, Ltd., a subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC).