NeuroDerm Announces Start of Bioequivalence Trial in Healthy Volunteers of ND0701

July 26, 2016

A New Continuous Subcutaneously Delivered Apomorphine Product Candidate for the Treatment of Advanced Parkinson’s Disease

• ND0701 complements the company’s product pipeline for the treatment of advanced Parkinson's disease  
• ND0701's proprietary formulation is designed to improve patient convenience by allowing delivery through a small, disposable, low-volume patch-pump and improve the tolerability and pain associated with current continuous apomorphine therapy -
• Company pursuing an abbreviated EU regulatory pathway based on demonstrating bioequivalence vs. commercially available apomorphine in healthy volunteers -

NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced that dosing has started in its EU bioequivalence trial (Trial 101) comparing ND0701, the company’s continuous, subcutaneously delivered liquid apomorphine-base formulation, with commercial continuous, subcutaneously delivered apomorphine-HCl. ND0701 is based on a novel, proprietary formulation of concentrated apomorphine-base that was designed to significantly improve patient convenience by enabling its administration via a small, disposable, low-volume patch-pump, and to improve the local tolerability and pain associated with current commercially available subcutaneously administered continuous apomorphine-HCl. Apomorphine is the most potent dopamine agonist used for the treatment of Parkinson's disease. The company's EU regulatory pathway for ND0701 is based on the demonstration of bioequivalence vs. commercial apomorphine-HCl in healthy volunteers. As previously disclosed, the company is currently designing the clinical and regulatory development plan of ND0701 in the United States.

Trial 101 is a crossover, randomized, two-sequence, 12 hour bioequivalence study that compares the pharmacokinetics, safety and tolerability of ND0701 with those of a reference commercial apomorphine product. The study is expected to enroll a total of 18 healthy volunteers and is expected to be completed in the fourth quarter of this year.

“Following multiple preclinical studies, this first clinical trial of ND0701, based on apomorphine, our second molecule for the treatment of Parkinson's disease, marks the introduction of an important new product candidate by NeuroDerm," said Oded S. Lieberman, PhD, NeuroDerm's CEO. "NeuroDerm's unique technology and knowhow in drug-device combinations that incorporate our novel, proprietary, drug formulations for continuous, subcutaneous delivery is being developed to allow us to offer Parkinson's patients a spectrum of new treatment alternatives aimed at different patient segments at different stages of the disease. ND0701 complements NeuroDerm's product line for treating Parkinson's disease beyond its ND0612 product candidates, which provide continuous subcutaneously administered levodopa/carbidopa, the gold standard therapy in Parkinson's disease. ND0701's proprietary formulation is designed to overcome some of the limitations of commercially available apomorphine formulations, which we believe have prevented their more widespread adoption. We believe that ND0701, if approved, may reposition apomorphine, the most potent dopamine agonist, as an effective therapy with an attractive profile, enabling its increased use as a relevant, non-surgical, convenient treatment alternative for Parkinson's disease patients, including severe patients who face limited treatment options.”

About ND0701
ND0701 contains apomorphine, the most potent dopamine agonist. Apomorphine is the most effective drug for the symptomatic treatment of Parkinson's disease after levodopa, which is considered the gold standard Parkinson's therapy. In addition, Apomorphine is approved both in the United States and in the EU for acute administration as rescue treatment for off periods in Parkinson's disease (currently administered subcutaneously as bolus injections) and only in the EU and not in the United States for continuous, subcutaneously delivered chronic therapy of advanced Parkinson's patients. Current commercial apomorphine formulations, based on apomorphine-HCl, are associated with low tolerability and pain and require daily subcutaneous administration of large volumes that limit its more widespread adoption. ND0701 is being developed as a chronic therapy of Parkinson's disease by continuous subcutaneous apomorphine administration. Based on a proprietary formulation of apomorphine-base, ND0701 is up to five times more concentrated than currently available commercial apomorphine-HCl products and should enable delivery through a small, low-volume, disposable patch-pump. In preclinical studies, ND0701 was also shown to have better local tolerability than a leading commercial apomorphine product. ND0701 is designed to offer superior convenience and better tolerability to current, continuous, subcutaneously administered apomorphine-HCl products.

http://www.globenewswire.com/news-release/2016/07/26/858908/0/en/NeuroDerm-Announces-Start-of-Bioequivalence-Trial-in-Healthy-Volunteers-of-ND0701-a-New-Continuous-Subcutaneously-Delivered-Apomorphine-Product-Candidate-for-the-Treatment-of-Advan.html