Results presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders demonstrated improvements in motor fluctuations and functional endpoints in patients with Parkinson disease (PD) treated with ND0612 (NeuroDerm, a Mitsubishi Tanabe Pharma Group Company, Jersey City, NJ) compared with those treated with orally administered levodopa/carbidopa (LD/CD). ND0612 is an investigational drug-device therapy that delivers continuous (24 hours/day) subcutaneous infusion of LD/CD.
The phase 3 double-blind, double-dummy (DBDD), parallel-group BouNDless study (NCT04006210) included 381 people with PD (PwP) on ≥4 oral LD/CD doses/day (≥400 mg/day LD) and experiencing ≥2.5 hours of daily "off" time. An initial 4-6 week open label immediate-release (IR) LD/CD dose adjustment was followed by 4-6 weeks of open-label ND0612 conversion which included IR-LD/CD as necessary. Participants were then randomized to a 12-week DBDD treatment group and received their optimized regimen of either ND0612 or IR-LD/CD. During the 12-week DBDD treatment regimen, those in the ND0612 group experienced an additional 1.72 hours of "on" time without troublesome dyskinesia (OTwoTD) (95% CI, 1.08 hours to 2.36 hours) compared with the IR-LD/CD group (P<.0001). Significant treatment effects of ND0612 vs IR-LD/CD were also observed in the following secondary endpoints: "off" time (-1.40 hours [-1.99 to -0.80], P<.0001), Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II (-3.05 [-4.28 to -1.81], P<.0001) and global impressions by patients (Odds ratio [OR] of improvement: 5.31 [2.67 to 10.58], P<.0001) and clinicians (OR: 7.23 [3.57 to 14.64], P<.0001). The most reported adverse events were fusion site reactions (84.2% during open-label conversion to infusion, 57.0% for ND0612 vs 43.5% for IR-LD/CD during the 12-week DBDD period).
“We are thrilled to present these positive results from our ongoing Phase 3 BouNDless trial, as they help us further understand the effect of ND0612 in people with Parkinson disease experiencing motor fluctuations,” said Yasutoshi Kawakami, President of Mitsubishi Tanabe Pharma America. “The outcome of this trial exemplifies our commitment to continue recognizing the unmet needs of people living with this disease, and we look forward to sharing additional study findings with the scientific community.”