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|NeuroDerm Presents Six Posters at the 21st International Congress of Parkinson’s Disease and Movement Disorders|
Tami Rachmilewitz, MD, Medical Director at NeuroDerm will present complete demographic data from trial 006 in an abstract titled, “Baseline characteristics of the population enrolled to a randomized clinical study of subcutaneous levodopa/carbidopa (ND0612) infusion in patients with advanced PD” (Abstract 1377).
Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm's high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson's disease. In March 2017, NeuroDerm announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints, with many patients experiencing a complete reduction of OFF-time to zero. Final safety and efficacy results from this trial were presented Monday in a late-breaking poster session (Abstract LBA41).
Baseline characteristics of the 38 patients enrolled in trial 006 were:
Baseline characteristics were similar between the R1 (24-hour administration of ND0612, n= 19) and R2 (14-hour administration of ND0612, n = 19) dose cohorts.
“Patients participating in trial 006 had baseline characteristics typical of advanced Parkinson’s disease that was already negatively impacting their motor function,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “That the trial met its primary, key secondary and additional secondary endpoints even in patients with advanced disease is highly encouraging and supports the growing body of data that suggests ND0612 may have potential as a transformative therapy for Parkinson’s disease.”
During today’s poster session,
Trial 101 Design
All subjects received an initial 1 mg/h dose of ND0701 on Day 1, followed by 2 mg/h ND0701 and 2 mg/h commercial apomorphine on subsequent dosing days in a randomized, partial cross-over manner, based on the recommendation of titrating commercial apomorphine for better tolerability. Subjects were randomized into 2 sequences to receive 3 consecutive doses.
PK blood samples were collected pre-dose and at predetermined time points up to 24 hours after start of infusion for determination of apomorphine plasma concentrations. Safety and tolerability assessments were done at specified time points until completion of the follow-up visit. Evaluation of safety parameters included analysis of adverse events (AEs), laboratory variables, vital signs, electrocardiograms (ECGs), infusion site reactions, and physical examination findings.
Trial 101 Final Results
ND0701 TEAEs were most frequently reported in the gastrointestinal and nervous system disorders system organ classes. The most frequently reported events within these categories were nausea, vomiting, dizziness, and somnolence; the lowest incidence was observed following ND0701 2 mg/h. The majority of TEAEs were mild in severity, none were severe. Only one TEAE was reported as local site reaction for a severe nodule (44 mm × 8 mm in size) following 2 mg/h commercial apomorphine ApoGo infusion. All post-dose physical examinations were normal, except for a muscle spasm associated with a pre-dose AE. There were no clinically significant findings in any vital signs, laboratory assessments and ECGs.
Erythema, swelling, and pain were noted at infusion sites for a few subjects across regimens, with no notable difference in incidence or severity between the ND0701 2 mg/h sites and the commercial apomorphine 2 mg/h sites; all incidents resolved by the 28-day follow-up visit. Infusion site nodules were reported more frequently and their incidence and severity were higher at sites administered commercial apomorphine 2 mg/h (10 small, 1 medium, and 1 severe nodule) compared with sites administered ND0701 2 mg/h (6 small nodules). More nodules were still evident at the 28-day follow-up visit following administration of commercial apomorphine 2 mg/h (n=4) compared with ND0701 2 mg/h (n=1).
“The results of trial 101 align with findings from previous preclinical studies that demonstrated expected good local safety and tolerability of ND0701 with comparable PK to commercial apomorphine,” noted Dr. Lieberman. “These findings support the continued development of ND0701, and we remain on track to meet with EU regulatory authorities to discuss the ND0701 clinical development plan in the first half of 2017 and to initiate a follow-on PK study by the end of the year.”
The following abstracts will also be presented during the poster session today from
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