Neuroderm (Nasdaq:NDRM) has announced success in an open trial of its drug for treatment of Parkinson's Disease. The trial included 38 patients. The trial results showed that the company's product reduces the patients' average off time from 5.5 hours a day before the trial, after receiving the currently accepted treatment, to 2.7 hours after treatment with the drug, a significant difference. The proportion of patients capable of functioning immediately upon waking up in the morning also rose.
The company share price jumped 22% on the news, boosting Neuroderm's market cap to $749 million, a record for the company and the highest market cap for a purely Israeli biomed company currently listed on Nasdaq. The company's share price is now 190% higher than it was in the company's 2014 IPO. Neuroderm has since conducted two offerings, each at a higher price than its precedessor.
Neuroderm has developed a unique formulation of Levodopa, the popular drug for treating Parkinson's Disease. The company's drug can be delivered directly to the bloodstream via the skin, instead of being taken orally, as at present. Direct delivery into the bloodstream is designed to facilitate a large dosage of the drug, and to prevent the sharp fluctuations in the levels of the drugs in the bloodstream that occur when the drug is taken orally. Among other things, off times are caused by a non-optimal dosage of the drug in the bloodstream, and Neuroderm's trial showed that its treatment reduces this problem.
In view of the trial results, the company is changing its development plan for Europe, where it will pursue the opposite track that it took in the US.
In Europe, based on the current results, the company has decided to expand its Phase III clinical trial in the hope of extending the outline of the product, in contrast to a situation in which it conducts a trial that only demonstrates success in delivering the drug to the bloodstream in the same levels as when taken orally (a bioequivalence trial), and does not provide clinical results (such as off times). The company will expand its trial in Europe from 150 to 240 patients in order to include in it both high and low dosages of the drug, as it did in the trial whose results were published today. This trial is scheduled to end in 2018. The bioequivalence trial planned by the company for registering the product in Europe is now being called off.
In the US, on the other hand, Neuroderm announced several months ago that instead of conducting a clinical trial, it would conduct only a bioequivalence trial showing the levels of the drug in the bloodstream. The company has obtained approval from the US Food and Drug Administration (FDA) to register the product on the basis of its bioequivalence trial only, and subsequently discontinued the clinical trial it was conducting in the US.
Both the cancelation of the US trial and the extension of the clinical trial in Europe on the basis of the trial results caused Neuroderm's share price to increase. The company is continuing its long-term safety trial scheduled for completion in 2018.
Published by Globes [online], Israel Business News - www.globes-online.com - on March 2, 2017
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