NeuroDerm (NASDAQ:NDRM) is a clinical-stage pharmaceutical company that had an initial public offering last month. It develops central nervous system (or CNS) product candidates that are designed to deliver continuous, controlled administration to overcome major deficiencies of current immediate-release treatments. In Parkinson's disease (or PD), NeuroDerm has four product candidates of levodopa/carbidopa (LD/CD) administered through small belt pumps for almost every stage of the disease. PD is a progressive neurodegenerative illness characterized by reduced dopamine (or DA) in the brain. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also known as "off" time. In addition, mainly as a result of excessive/intermittent oral doses of LD aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia. The "off" time and dyskinesia interfere with day-to-day functions and cause severely disability. LD crosses into the brain and converts into DA to replenish the reduced brain DA levels. At any given time, 70% to 80% of patients are on LD, but due to the low oral absorption and short half-life of LD, multiple LD/CD daily doses are required, which result in erratic "off" and "on" periods due to sharp LD fluctuations.
ND0612L and ND0612H are candidates to be the first convenient product with continuous 24-hour administration. ND0612L is for moderate stage PD, while ND0612H is for severe stage PD; both target patients for whom oral drugs are no longer effective. ND0612H in particular could be an alternative to currently offered surgical options such as deep brain stimulation or LD/carbidopa intestinal gel, which is delivered via a tube permanently implanted into the duodenum, the upper part of the small intestine. ND0612L and ND0612H are liquids administered subcutaneously through a small belt-worn pump similar to the administration devices used to deliver insulin to diabetic patients (see figures below) and are designed to avoid morning "off" time and allow a good night's sleep.
ND0612L for moderate stage Parkinson's disease (PD)
ND0612H for severe stage PD
Today, NeuroDerm announced that ND0612H and ND0612L maintained clinically-significant plasma LD levels in a Phase IIa pharmacokinetic study of 16 advanced PD patients. A top-line, intent-to-treat (or ITT) results showed that LD plasma levels were proportionate to dose. Per-protocol (or PP) analysis excluded three data sets from two patients because they were also on oral LD, but demonstrated similar LD plasma values. ITT analysis includes all patients, while PP includes only those who completed the trial; results are much more reliable when both agree, and here they do. All patients did complete the study and treatment did not raise safety and tolerability concerns, causing only the usual minimal and transient local reactions expected at the infusion site. The positive data allows NeuroDerm to proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015.
NeuroDerm has one other product in Phase II. ND0801 is aimed at treating cognition disorders associated with CNS diseases, such as Alzheimer's disease, Parkinson's disease and schizophrenia; it is currently being tested in an open-label, proof-of-concept dose escalation study on 45 adult patients with Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD). Final results are due by the first half of 2015.
Despite the positive news, NeuroDerm is not yet at its IPO price of $10.00 per share. With a market cap still under $200 million even after today's action, NeuroDerm is a moderate speculative play. It that may not match the 1000% rise of Acadia Pharmaceuticals (NASDAQ:ACAD) to its current $3.2 billion valuation, but has less risk due to NeuroDerm candidates being "gold-standard" medications, just packaged in more accurate delivery systems.
Disclosure: The author is long ACAD.
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