NeuroDerm Ltd. (NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today reported human factors data from a usability study focused on the interactions between Parkinson’s disease (PD) patients and the mini-pump device used to administer ND0612, the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation. The data were presented today at the 4th World Parkinson Congress (WPC), which is taking place in Portland, Oregon.
Tamar Rachmilewitz, M.D., Medical Director at NeuroDerm, presented the data in a poster titled, “ND0612 – a newly developed liquid levodopa/carbidopa formulation administered continuously subcutaneously by a mini-pump – patient use perspective,” (Abstract P31.16) during the Clinical Sciences: Pharmacological Therapy session held from 11:30 a.m. – 1:30 p.m. PDT.
“The ND0612 mini-pump delivery system was designed to enable a patient-friendly approach to managing Parkinson’s disease, and the data presented at this conference demonstrate that this goal has been achieved,” said Dr. Rachmilewitz. “Study results show that, following appropriate training, patients and their partners were able to independently operate the pump effectively in a simulated home setting. The data supported our assumption that ND0612 can be controlled by the patient as a simple-to-operate solution designed to achieve constant levels of LD in the blood and improve motor fluctuations that cannot be adequately controlled with oral therapy that may otherwise require surgical intervention.”
The study included 15 pairs of subjects, consisting of a patient with moderate to severe PD and his/her spouse, partner or caregiver (partner). Each pair received four 90-minute training sessions on how to set up and operate the pump system. These included training aids and materials, step-by-step live demonstrations and a pictorial patient guide. The training sessions were followed by a simulated assessment during which the participants were expected to carry out the operating steps required to deliver the subcutaneous infusion unaided. The performance of the correct tasks was evaluated at the end of the sequence.
All 15 pairs were able to assemble and operate the pump, demonstrating user-learning ability and overall user satisfaction with the device. The materials used in the training sessions were shown to be effective in aiding PD patients to achieve proper operation of the pump system. Importantly, despite the patients’ inherent motor difficulties due to their PD, they were able to perform 57% of the total task steps independently and without help from their partners. There was no difference in the performance of pairs for patients with severe PD compared to moderate PD.
“These results validate the ease of use of the ND0612 mini-pump delivery system, even in patients with motor dysfunction,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “NeuroDerm is committed to developing novel therapies that not only improve the care and outcomes for PD patients but do so in a way that is straightforward, minimally invasive and designed to decrease patient dependence. A growing body of data suggests that ND0612 has the potential to transform the lives of PD patients, and the data presented at this conference show that this potentially transformative product candidate can be delivered conveniently in patients’ homes.”
Four additional abstracts containing previously reported data were presented during the conference:
- “ND0701: a novel safe concentrated apomorphine formulation for continuous subcutaneous administration via a patch pump (Abstract P31.18).”
- “Stable levodopa plasma levels with ND0612 (levodopa/carbidopa for subcutaneous infusion) in Parkinson’s disease (PD) patients with motor fluctuations (Abstract P35.02, trial 003).”
- “Pharmacokinetic profile of ND0612L (levodopa/carbidopa for subcutaneous infusion) in patients with moderate to severe Parkinson’s disease (Abstract P35.13, trial 004).”
- “A randomized controlled clinical study to evaluate the efficacy and safety of subcutaneous levodopa/carbidopa (ND0612H) in patients with advanced Parkinson’s disease (Abstract P35.12, trial 006).”
About ND0612H and ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD solution. Previously completed Phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including "off time" reductions when added to optimal oral standard of care. ND0612H, intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.
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