NeuroDerm Initiates Phase 2 Study of ND0801 in Patients with ADD/ADHD
Ness Ziona, November 9, 2010 / — 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, amongst others, the treatment of cognitive impairment in several disorders including Alzheimer’s disease, schizophrenia and advanced Parkinson’s disease.
Based on pre-clinical studies, ND0801 is believed to work by overcoming the rapid desensitization of nicotinic receptors that contributes to nicotine addiction and that otherwise occurs following repeat applications of nicotine. Nicotinic brain circuitry has 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 use downregulates the actions of the nicotinic receptors. The company hopes that should ND0801 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 dermal CNS patch 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”.
NeuroDerm is an emerging pharmaceutical company that develops therapeutic dermal patches for the treatment of CNS diseases. NeuroDerm’s technology is based on proprietary reformulations and/or combinations of well established drugs to achieve a new clinical effect or improved clinical benefit. The company’s lead products include ND0611, a skin patch for the treatment of Parkinson’s disease and ND0801, for the treatment of cognitive dysfunctions in ADD/ADHD and other CNS diseases. Other products for the treatment of various CNS diseases are in different stages of development. NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.