NeuroDerm Kicks Off Phase IIA Trial For Parkinson's Drug

Clinical stage pharmaceutical firm NeuroDerm announced that the first patients have been enrolled and dosed in its Phase IIA study for ND0612H in Parkinson’s disease.

ND0612H is a high-dose form of the company’s proprietary liquid levodopa/carbidopa (LD/CD) drug formulation, subcutaneously administered via a belt-pump. The company said that the drug targets patients with severe stage Parkinson’s disease that are resistant to oral levodopa and who can only be treated with limited therapeutic options. These include invasive surgical interventions, including continuous intra-duodenal LD/CD gel infusion and Deep Brain Stimulation, which are also linked with serious complications.

Oded Lieberman, NeuroDerm CEO, said, “Because of its subcutaneous delivery route, ND0612H should offer these patients, for the first time, the advantage of continuous levodopa therapy without having to go through surgery that is required for alternative treatments. We hope that severe Parkinson’s patients will be able to benefit in the future from a widely accessible, highly effective new treatment alternative that may have a dramatic influence on their lives.”

Parkinson’s disease is caused by the death of dopaminergic brain cells that leads to decreased levels of dopamine signaling in the brain. The disease affects around 5 million around the world, most of which are treated with the gold standard oral levodopa. However, oral levodopa becomes ineffective in patients with advanced PD and leads to clinical/motor complications in patients

The Phase IIA study will assess the pharmacokinetic profile of the drug, as well as the steady state of levodopa blood levels achieved by various doses of ND0612H. The trial will also include the low-dose form of liquid LD/CD ND0612L. Both drugs work to reduce motor complications in the disease through round-the-clock maintenance of steady, therapeutic levodopa plasma levels in PD patients. NeuroDerm reports that ND0612L has just finished a separate Phase II study with the help of a grant from The Michael J. Fox Foundation for Parkinson’s Research.

The company recently received $16 million in funding for the advancement of the clinical and regulatory development of its drugs, particularly its candidates for the treatment of Parkinson’s disease.