Mitsubishi Tanabe Pharma America Presents Open-Label Extension Outcomes and Additional Data from Phase 3 BouNDless Trial of Investigational ND0612 in Parkinson's Disease

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Sep 30, 2024, 09:00 ET

One-year outcomes from open-label extension to BouNDless study reaffirm previously published data regarding long-term efficacy of ND0612

Additional new data evaluating quality of life, daily motor experiences and motor fluctuations favor ND0612 treatment vs. oral immediate-release levodopa/carbidopa

JERSEY CITY, N.J., Sept. 30, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of three posters discussing new data from the pivotal Phase 3 BouNDless trial (NCT04006210) and its ongoing open-label extension (OLE) evaluating investigational ND0612 in people with Parkinson's disease (PD) experiencing motor fluctuations, as part of the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS). ND0612 is being studied as a 24-hour, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD).

The data highlight one-year outcomes from the BouNDless-OLE phase that are consistent with previously-reported 12-week data from the study evaluating the long-term efficacy of ND0612. Additional presentations discussed findings from patient-reported outcomes favoring ND0612 vs. oral immediate-release (IR) LD/CD across various measures of quality of life (QoL) and the effect of treatment on motor signs and motor experiences of daily living (m-EDL).

"The longer-term data presented at MDS provide insights into the potential of ND0612 to not only improve symptoms, but also maintain its efficacy, which may provide patients with a meaningful reduction in symptom burden," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These findings reinforce our commitment to studying ND0612, if approved, as a potential new treatment option for people with Parkinson's disease experiencing motor fluctuations, as well as ensuring the latest scientific knowledge is continuously shared with the community."

Key highlights presented at the meeting include:

Abstract #653: Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) for Motor Fluctuations in Parkinson's Disease
- Patients who completed the double-blind double-dummy (DBDD) phase of the BouNDless study were eligible to enter the OLE phase. At six months, patients treated with ND0612 experienced an average reduction of 2.2 hours in daily OFF time and an increase of 2.4 hours in daily ON time without troublesome dyskinesia. These results were sustained at 12 months, showing an average reduction of 2.02 hours in OFF time and an increase of 2.11 hours in ON time without troublesome dyskinesia.
- In addition, patients with one or more hours of ON time with troublesome dyskinesia at ND0612 initiation (n=45) experienced an average reduction of troublesome dyskinesia by 1.5 hours at 12 months, further demonstrating sustained efficacy.

Abstract #648: Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized, Active-Controlled Study
- Following two sequential open-label periods to optimize oral IR-LD/CD and ND0612, study participants were randomized to a 12-week DBDD treatment period with either ND0612 or IR-LD/CD regimens. Change in QoL was assessed at the end of the DBDD period across eight domains of daily living using the PD Questionaire-39 (PDQ-39).[1]
- At the end of 12 weeks, patients in the continuous 24-hour ND0612 treatment group reported improved QoL (-2.1 [-3.7, -0.6]) compared to no change in the IR-LD/CD group (+0.6 [-0.9, 2.1]). The PDQ-39 domain analyses favored ND0612 treatment in most domains; mean changes were mobility, bodily discomfort, cognition, activities of daily living, stigma, social support, communication and emotional well-being.

Abstract #685: Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Signs of PD and Experiences of Daily Living
- During the BouNDless trial, at both eight and 12 weeks, treatment with ND0612 showed superior improvements in m-EDL vs. oral IR-LD/CD, as measured by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III scores.
- Additionally, a post-hoc analysis of treatment differences for a number of motor signs showed treatment with ND0612 was superior to oral IR-LD/CD, with improvements observed in postural instability-gait disorder (–0.26 vs. 0.02, p=0.0012), speech and oral health (–0.11 vs. 0.05, p=0.0140), tremor (–0.15 vs. –0.05, p=0.0992) and self-care (–0.08 vs. 0.09, p=0.0528). No relevant differences were observed for rigidity and bradykinesia.

In the BouNDless trial, ND0612 was generally well tolerated. In patients treated with ND0612, the most common systemic treatment emergent adverse events (TEAEs) reported during the open-label run-in period of the study included dyskinesia (9.3% of subjects), ON and OFF phenomenon and fall (each reported in 5.3% of subjects). During the maintenance period of the clinical trial, 2% of patients in both the ND0612 and oral IR-LD/CD-only groups reported dyskinesia. Additionally, only 6% of study participants treated with ND0612 discontinued the trial during the maintenance period due to any reason – including 5% due to AEs – compared to discontinuation rates of 6% and 3%, respectively, of study participants in the oral IR-LD/CD groups.[2]

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 Parkinson's Disease questionnaire. Oxford University Innovation. Published August 31, 2023. https://innovation.ox.ac.uk/outcome-measures/parkinsons-disease-questionnaire-pdq-39-pdq-8/
² Espay A, Stocchi F, Pahwa R, et al (2024). Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomized, double-blind, double-dummy, multicentre trial. Lancet Neurol. https://doi.org/10.1016/S1474-4422(24)00052-8.

SOURCE Mitsubishi Tanabe Pharma America