NeuroDerm Announces Positive Phase 2 Results of Parkinsons Vaccine
NeuroDerm Ltd., a clinical-stage pharmaceutical company developing
drugs for central nervous system (CNS) diseases, announced that patients
with moderate to severe Parkinson’s disease who received continuous,
subcutaneous doses of liquid levodopa/carbidopa (LD/CD) (ND0612L)
exhibited clinically significant reduction in fluctuations of plasma
levodopa concentrations compared to patients receiving a placebo as part
of a randomized, placebo-controlled, double-blinded Phase 2 study.
Patients receiving ND0612L also experienced a corresponding in-clinic
two-hour reduction over placebo in “off” time, improved sleep, better
quality of life and global clinical improvement without an increase in
troublesome dyskinesia.
The topline results were presented at The Michael J. Fox Foundation’s 2014 Parkinson’s Disease Therapeutics Conference in New York.
Also at the conference, the company presented preliminary, partial results from a Phase 2a safety and pharmacokinetic study with its high-dose, continuous, subcutaneously-delivered liquid LD/CD product, ND0612H. Results demonstrated consistent levels of levodopa in plasma, proportionate to dose, achieving daytime concentrations of approximately 1,500ng/ml and 1,900ng/ml, alone and with oral entacapone, respectively. Based on those results, the company believes that ND0612H could provide an effective day and night treatment option for the majority of advanced Parkinson’s disease patients who are considering continuous LD/CD intra-duodenal gel infusion therapy (LCIG, DuoDopa) or deep brain stimulation (DBS). The company anticipates final results of this study by the end of the year.
“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 Sheila Oren, M.D., NeuroDerm vice president of clinical and regulatory affairs, who presented the data of both studies at the meeting. “These encouraging results reinforce our belief that steady levodopa concentrations translate to clinical benefits. The clinically-significant impact on reduction in ‘off’ time and the positive outcomes from the other exploratory efficacy endpoints, suggest that ND0612L should have a profound impact on patients’ quality of life by greatly improving disease symptoms, while ND0612H may be a very attractive alternative to surgical intervention in advanced patients.”
The topline results were presented at The Michael J. Fox Foundation’s 2014 Parkinson’s Disease Therapeutics Conference in New York.
Also at the conference, the company presented preliminary, partial results from a Phase 2a safety and pharmacokinetic study with its high-dose, continuous, subcutaneously-delivered liquid LD/CD product, ND0612H. Results demonstrated consistent levels of levodopa in plasma, proportionate to dose, achieving daytime concentrations of approximately 1,500ng/ml and 1,900ng/ml, alone and with oral entacapone, respectively. Based on those results, the company believes that ND0612H could provide an effective day and night treatment option for the majority of advanced Parkinson’s disease patients who are considering continuous LD/CD intra-duodenal gel infusion therapy (LCIG, DuoDopa) or deep brain stimulation (DBS). The company anticipates final results of this study by the end of the year.
“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 Sheila Oren, M.D., NeuroDerm vice president of clinical and regulatory affairs, who presented the data of both studies at the meeting. “These encouraging results reinforce our belief that steady levodopa concentrations translate to clinical benefits. The clinically-significant impact on reduction in ‘off’ time and the positive outcomes from the other exploratory efficacy endpoints, suggest that ND0612L should have a profound impact on patients’ quality of life by greatly improving disease symptoms, while ND0612H may be a very attractive alternative to surgical intervention in advanced patients.”
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