December 31, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Israel-headquartered biopharmaceutical company NeuroDerm Ltd. announced on Dec. 30 that its Parkinson’s disease drug, ND0612H, could potentially be an effective alternative to treatments that require surgery.
The news came after researchers examined the results of a study designed to assess the tolerability and safety of proprietary liquid levodopa/carbidopa product candidates, ND0612H and ND0612L.
Reuters reported that NeuroDerm Ltd. shares doubled after the results were made public. Shares increased 118 percent to $13.49, which crossed the initial public offering price of $10 for the first time. The company announced its IPO back in November.
“Maintaining consistent levodopa concentrations has been the most significant hurdle in Parkinson’s disease therapy,” said Sheila Oren, NeuroDerm‘s vice president of clinical and regulatory affairs. “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. ND0612H is designed to be delivered continuously, thus we believe it should offer a simple and effective treatment option that will minimize the need for surgical intervention in advanced Parkinson’s patients.”
Because the drug has a short half-life in its oral form, patients must take multiple doses daily. A steady delivery of the drug can only currently be achieved through an invasive surgical procedure. The study showed that NeuroDerm’s drug did not raise safety or tolerability concerns.
“These results add to the growing body of clinical data confirming our thesis that continuous, subcutaneous delivery of LD/CD leads to more consistent therapy, which we expect to have a dramatic effect on patient outcomes and quality of life, replacing in most cases the need for surgical intervention,” said Oded Lieberman, CEO of NeuroDerm. “Based on these positive PK results, we will proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015.”
The Presentation of Promising Data
NeuroDerm released the results of a phase 2 study that looked at ND0612H and ND0612L for the treatment of Parkinson’s disease back in October. The results showed that the drugs could significantly reduce fluctuations of plasma levodopa concentrations, improve sleep and increase quality of life in patients.
“The results of these two mid-stage studies show that continuous, subcutaneous dosing with the world’s first-ever liquid formulation of levodopa, the gold standard treatment for Parkinson’s disease, helps overcome the poor pharmacokinetics associated with oral therapy that often have debilitating ramifications for patients,” said Oren. “These encouraging results reinforce our belief that steady levodopa concentrations translate to clinical benefits.”
