NeuroDerm's Parkinson's Therapy Shows Promising Phase 2 Results

By C. Rajan, contributing writer

Israeli CNS focused biotech company, NeuroDerm, has just announced positive topline results from the Phase 2 study of its low-dose liquid levodopa/carbidopa combination (ND0612L) in patients with moderate to severe Parkinsons disease.

The results showed that continuous, subcutaneous dosing of the drug combination resulted in significant reduction in fluctuations of plasma levodopa concentrations in patients compared to placebo. Patients receiving ND0612L also experienced significant improvement in disease symptoms without an increase in the dyskinesia side effect.

The company presented these results at The Michael J. Fox Foundations 2014 Parkinsons Disease Therapeutics Conference in New York this week, along with partial results from its other Phase 2 study of the high-dose form of this drug combination, ND0612H.

The Phase 2 study of ND0612H, which began in September, showed that the high-dose form helped maintain consistent levels of plasma levodopa in patients, alone and with oral entacapone, making it an effective day and night treatment option for severe cases of Parkinsons. The company expects to have the final results from this study by the end of this year. The high-dose form is being developed for advanced Parkinsons disease patients, as it has the potential to prevent or delay the need for surgical intervention in such patients.

Both ND0612L and ND0612H are NeuroDerms proprietary liquid levodopa/carbidopa (LD/CD) drug formulation and are designed to be administered continuously under the skin by a belt-pump. They help to maintain steady, therapeutic levodopa plasma concentrations in patients, which is known to help reduce motor complications in Parkinsons disease patients.

Neuroderm received a $1 million grant last year from The Michael J. Fox Foundation for Parkinsons Research to support the clinical development of ND0612L and ND0612H in Parkinsons disease.

Based on the positive results of these two studies, the company is planning to begin pivotal Phase 3 studies of longer duration with more patients next year.

The results of these two mid-stage studies show that continuous, subcutaneous dosing with the worlds first-ever liquid formulation of levodopa, the gold standard treatment for Parkinsons disease, helps overcome the poor pharmacokinetics associated with oral therapy that often have debilitating ramifications for patients, said Sheila Oren, M.D., NeuroDerm VP of clinical and regulatory affairs.

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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NeuroDerm's Parkinson's Therapy Shows Promising Phase 2 Results