The experiment, in 24 Parkinson's patients in an advanced stage of the disease, was a crossover, randomized, double-blind, with 6 treatment arms performed against a placebo
Neuroderm, which develops transdermal drugs for diseases of the central nervous system (CNS), has successfully completed a phase 2 trial in advanced-stage patients with ND0611, a transdermal drug for the treatment of Parkinson's disease. The results of the trial support the continued clinical and regulatory development of the drug. The full results will be presented at the conference International Science coming soon.
The trial, in 24 Parkinson's patients in an advanced stage of the disease, was crossover, randomized, double-blind, with 6 treatment arms performed against placebo. The experiment successfully achieved all of its primary and secondary objectives. The purpose of the experiment was to test the safety of ND0611 as well as its effect on levodopa concentrations in the blood when it was administered in addition to the oral administration of each of the three leading levodopa drugs on the market (Sinemet®, Sinemet® CR and Stalevo®). The analysis of the results shows that the use of ND0611 showed a marked improvement of high clinical and statistical significance in all the pharmacokinetic parameters tested. A significant slowing of levodopa clearance and a significant increase in its bioavailability were seen. In this way ND0611 allows maintaining a more constant blood level of levodopa.
Dr. Oded Lieberman, Chairman and CEO of Neuroderm, stated that: "This impressive success in the Phase 2 trial raises the possibility that ND0611 will become a new benchmark for the treatment of Parkinson's patients. The ND0611 is unique and revolutionary in its treatment approach as it is the first time that carbidopa is administered directly systemically and not through the digestive system, thus improving the life time of levodopa, which is extremely important for patients and their deteriorating quality of life. The effect of ND0611 is particularly impressive since it resulted in significant improvement when it was given with all the leading levodopa drugs - including the drug that is considered the best today. We can therefore hope that in the coming years we will be able to offer Parkinson's patients a significant improvement in the oral levodopa treatment."
0611 ND is Neuroderm's leading drug and is intended for the treatment of Parkinson's disease. Today, the leading treatment for Parkinson's patients is carried out using the levodopa pill (which 'compensates' for the lack of dopamine characteristic of the disease) but it loses its effect in the body in a short time. Taking it orally does not allow maintaining a constant level in the blood and makes the development of motor complications and a decrease in the effectiveness of the pill possible. The ND0611 is based on a unique formulation that should significantly improve the blood availability of orally administered Levodopa.
The drug market for Parkinson's disease is currently estimated at over three billion dollars per year. A large number of leading pharmaceutical companies sell products in the field of drug therapy for Parkinson's, including Glaxo-Smith-Kline, Novartis, Boehringer Ingelheim, Eli Lilly, Teva and UCB. The number of Parkinson's patients in the world is estimated at about 6 million patients, of which, according to the American Parkinson's Association, about 1.5 million are in the USA. About 70-80% of Parkinson's patients are treated with Levodopa.
Neuroderm was established at the beginning of 2003 as part of the Capital Point Group. The company specializes in developing drugs administered through the skin to treat diseases of the central nervous system. The company's first and leading product, the 1,ND061 is a patch for the treatment of Parkinson's patients which is the first drug in the world for systemic intervention in the level of levodopa (Levodopa) in the blood. So far, Neuroderm has raised only about 8.57 million dollars. This clinical trial was supported by the Michael G. Fox Foundation for Parkinson's Disease Research with a grant of one million dollars for its investors, including Robert Taub, founder of the biopharmaceutical company Omrix (NASDAQ:OMRI), Uwe Wacher, Dr. Shmuel Kabili, an inventor and researcher who holds a large number of patents in the field of biotechnology and Hammam Ofakim. The company is located in the Science Park in Rehovot.
