Mitsubishi Tanabe Pharma America (MTPA) has announced that a Phase III trial of its Parkinson’s disease (PD) candidate ND0612 has met its primary endpoint.
The multi-centre, randomised, double-blind double-dummy (DBDD), BouNDless trial (NCT04006210) evaluated the efficacy, safety and tolerability of ND0612 (levodopa/carbidopa), compared to oral intermediate-release (IR) levodopa/carbidopa (LD/CD) in people with PD experiencing motor fluctuations.
The results of this trial come after two previous Phase III trials of the candidate were withdrawn, according to GlobalData’s Pharmaceutical Intelligence Centre.
GlobalData is the parent company of the Clinical Trials Arena.
The trial met its primary endpoint and the first four secondary endpoints. These most recent results, which follow positive topline data reported earlier this year, were presented at the International Congress of Parkinson's Disease and Movement Disorder Society (MDS) in Copenhagen, Denmark, between 27 to 31 August 2023.
MTPA president Yasutoshi Kawakami said: "We are thrilled to present these positive results from our ongoing Phase III BouNDless trial, as they help us further understand the effect of ND0612 in people with Parkinson's disease experiencing motor fluctuations.
"The outcome of this trial exemplifies our commitment to continue recognising the unmet needs of people living with this disease, and we look forward to sharing additional study findings with the scientific community."
Trial results
Patients in the experimental group of ND0612 demonstrated favourable efficacy over IR-LD/CD. Data showed a statistically significant increase (p<0.0001) of 1.72 hours in "ON" time without troublesome dyskinesia. The trial also demonstrated positive and clinically meaningful results for the first four secondary endpoints, including a reduction of "OFF" time (p<0.0001).
Infusion site reactions were the most reported with 57% for ND0612 and 43% for IR-LD/CD. Certain infusion site reactions, including haematoma, infection, erythema, pain and infusion eschar, were more frequent in the ND0612 group compared to oral LD/CD.
The safety profile of ND0612 was consistent with that of oral standard of care LD/CD. 6.3% of study participants discontinued the trial during the DBDD period due to any reason – including 5.5% due to adverse events.
About ND0612
ND0612 is an investigative drug and device combination therapy for people with Parkinson's disease (PD) experiencing motor fluctuations. It is administered as a continuous, 24-hour-a-day subcutaneous (SC) infusion of liquid LD/CD.
MTPA subsidiary NeuroDerm is leading the development of ND0612. MTPA to commercialise the therapy in the US subject to receiving regulatory approval.
