NeuroDerm Parkinson's Drug Shows Promise In Mid-Stage Study

12/30/2014 9:52 AM ET

Clinical-stage pharmaceutical company NeuroDerm Ltd. (NDRM: Quote), which went public in November, announced Tuesday topline results for a mid-stage study for its proprietary liquid levodopa/carbidopa (LD/CD) product candidates as a treatment for Parkinson's disease.

Following the announcement, the company's shares are skyrocketing more than 49 percent in early deals.

The company said the continuous, subcutaneous delivery of the liquid product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. The company added that ND0612H, the higher dose version, provided an effective alternative to current treatments that require surgery.

"Maintaining consistent levodopa concentrations has been the most significant hurdle in Parkinson's disease therapy. The results from this study demonstrate that ND0612H can reach high LD plasma levels that, to date, could only be reached and maintained by products that require surgical intervention," said Sheila Oren, NeuroDerm's Vice President of Clinical and Regulatory Affairs.

The phase IIa study was conducted on 16 patients with an advanced form of Parkinson's disease having motor fluctuations that was chronically treated with standard of care oral LD/CD. The primary endpoints of the study were to assess the safety, tolerability and pharmacokinetics (PK) of six dose regimens of ND0612H and ND0612L.

The patients were treated with ND0612L (n=9) or ND0612H (n=7) for eight hours per day, for three consecutive days, with high and low doses of CD, and with adjunct oral entacapone. The LD/CD product candidates are continuously administered subcutaneously through a belt-worn pump.

The trial results showed that patients receiving ND0612H achieved maximum daytime levodopa plasma concentrations of 1,333ng/ml and 1,807ng/ml with oral entacapone added.

Meanwhile, patients receiving ND0612L achieved maximum daytime concentrations of 528ng/ml and 596ng/ml with oral entacapone added.

The company confirmed that all patients completed the study and treatment with ND0612L and ND0612H did not raise safety and tolerability concerns.

Rehovot, Israel-based NeuroDerm focuses on developing drugs for central nervous system (CNS) diseases.

The company noted that it will now proceed with the clinical development of ND0612H and ND0612L in the U.S. and the European Union in 2015, based on the promising mid-stage trial results.

Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions. 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.

In Tuesday's regular trading session, NDRM is currently trading at $9.23, up $3.05 or 49.35% on a volume of 2.32 million shares. In the past 52-week period, the stock has been trading in a range of $5.67 to $9.45.

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