NeuroDerm, Ltd. announced today that patient enrollment has begun in a Phase 2a clinical study of ND0801, a new product for the treatment of Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) in adults. ND0801, based on a new, proprietary combination with nicotinic actions, is being developed as a dermal patch and will be evaluated for the treatment of cognitive impairment in several disorders including Alzheimer's disease, schizophrenia and advanced Parkinson's disease, among others.
Nicotinic brain circuitry has previously been shown to be involved in a variety of neurological diseases and disorders and, consequently, nicotinic receptors are the target of several agonist drugs under development. Nicotine, however, has had limited potential as a drug because its repeated use downregulates the actions of the nicotinic receptors. Based on pre-clinical studies, ND0801 is believed to work by preventing the desensitization of nicotinic receptors (contributing to nicotine addiction) that otherwise occurs as a result of repeat nicotine applications. The company hopes that, should it overcome the desensitization of nicotine effects, ND0801 may be beneficial in the treatment of cognitive and other central nervous system dysfunctions.
This Phase 2a study, conducted at two centers in Israel, is planned to enroll 45 ADD/ADHD patients. The trial will examine the safety, tolerability and optimal therapeutic dose of ND0801, and will evaluate the cognitive improvement in these subjects following treatment with ND0801, using standard cognition scale tests.
"The start of this clinical study with ND0801 is a major milestone for NeuroDerm. It marks the entry into clinical development of the company's second, innovative product, for the treatment of cognitive impairment," said Oded S. Lieberman, PhD, NeuroDerm's Chairman and CEO. "Nicotine is believed to have great potential for the treatment of many diseases. We hope that ND0801 might become the first patch to overcome the desensitization of nicotinic receptors, thereby offering an exciting new treatment option in CNS diseases."
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