- ND0612 head-to-head pilot PK results and ND0701 first-in-man PK results to also be presented -
- ND0612 clinical data featured in four additional abstracts -
REHOVOT, Israel, May 23, 2017 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders, today announced that complete data from trial 006 will be showcased in a late-breaking poster session at the 21st International Congress of Parkinson’s Disease and Movement Disorders, taking place June 4-8, 2017 in Vancouver, B.C. 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. ND0612 will be featured in five additional abstracts, and data from pharmacokinetic (PK) studies of ND0701 will also be presented.
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. Sheila Oren, MD, MBA, Chief Medical Officer at NeuroDerm will present the complete results from this trial in a poster titled, “Safety, efficacy and tolerability of continuous SC LD/CD (ND0612) infusion in PD patients with motor fluctuations,” (Abstract LBA41) in a late-breaking abstract session on Wednesday, June 7, from 1:15 p.m. to 2:45 p.m. PT.
Tami Rachmilevitz MD, Medical Director at NeuroDerm will present additional 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) in a poster session on Thursday, June 8, from 1:15 p.m. to 2:45 p.m. PT.
Previously unannounced complete results from a head-to-head pilot PK comparison trial (trial 005) evaluating ND0612 and intra-duodenally delivered LD/CD gel suspension requiring surgical intervention (DUODOPA®/DUOPATM) will also be presented by Liat Adar, PhD, Director Clinical Pharmacology and Personalized Medicine at NeuroDerm, in an abstract titled, “Pharmacokinetic profile of continuous levodopa/carbidopa delivery when administered subcutaneously (ND0612) versus duodenal infusion,” (Abstract 1337). This abstract will also be presented in the poster session on Thursday, June 8, from 1:15 p.m. to 2:45 p.m. PT. NeuroDerm reported topline results from this study in June 2016, with topline results demonstrating comparable bioavailability to DUODOPA®.
Additionally, Cecile Durach, Medical Director of Europe at NeuroDerm will present first-in-man clinical results for ND0701, the company’s continuous apomorphine product. The abstract, titled, “ND0701: A new concentrated formulation of Apomorphine for continuous subcutaneous administration – human PK data” (Abstract 1391) will be presented on Thursday, June 8 from 1:15 p.m. to 2:45 p.m. PT.
The following abstracts will also be presented during the poster session on Thursday, June 8 from 1:15 p.m. to 2:45 p.m. PT:
- “Patient perspectives using the ND0612 mini-pump” (Abstract 1384)
- “ND0612 (levodopa/carbidopa for subcutaneous infusion) achieves stable levodopa plasma levels when administered in low and high doses in patients with PD” (Abstract 1386)
- “Identification of the optimal carbidopa concentration in subcutaneously administered ND0612” (Abstract 1393)
NeuroDerm is a clinical-stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. NeuroDerm has three product candidates in different stages of development that offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. NeuroDerm has developed a line of levodopa and carbidopa (LD/CD) product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD product candidates are ND0612L and ND0612H, which are used for treatment of moderate and advanced Parkinson’s disease patients, respectively, and which are delivered subcutaneously. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from moderate to severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2016 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Oded S. Lieberman, PhD, CEO
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