ND-1004

Natural Product based Neuroprotectant for Early Stage Parkingson's Disease
TECHNOLOGY PROFILE

Neurodyn Inc. (neurodyn.ca) is a Canadian biotechnology company which identifies, validates and develops natural BioActives for the early treatment of neurological diseases.  Neurodyn is conducting a natural product drug development program with a botanical extract that shows compelling evidence for protection of early stage Parkinson’s disease (PD). PD is the second-most common progressive neurodegenerative disease, and is associated with a significant burden of illness and cost to society.  No therapy has yet been identified that can definitively slow or stop the progression of PD. 

ND 1004 has shown compelling efficacy in animal models of PD, and Neurodyn’s proprietary slow progression model of PD.  The company is screening the ND 1004 extract in order to identify those individual components which are primarily responsible for its neuroprotective effects, with the goal of developing an optimally neuroprotective formulation for US FDA regulatory approval as a medical food.  The extract has an exceptional and well documented historical safety profile.

ND 1004 is being designed to:

• intervene at the earliest stages of PD
• significantly slow progression of PD, especially at early stages where no therapies are available
• be used as a prophylactic by those that may be at risk of developing PD
• represent the first PD-optimized natural product formulation, with patent protection
• proceed through human clinical trials, showing relevant outcome measures for PD improvement
• receive US FDA designation as a medical food

Natural products can play a significant role in de-risking of the drug discovery and commercialisation process and offer a number of advantages over traditional drug development programs:

• known safety profile and traditional evidence of efficacy in certain disease conditions
• reduced costs associated with lower regulatory evidentiary burden, with lower clinical trial costs
• faster time to market and reduced development costs

Timelines
The company expects to begin animal trials with an optimized formulation in August 2012 and human clinical trials are scheduled to begin in early 2013.

Business Objective
There is high interest in the biopharmaceutical sector for novel classes of chemistry that have a safe, demonstrated capacity for neuroprotection.  Neurodyn is seeking a R&D collaboration with a suitable pharma player to assist in taking ND 1004, a proprietary natural therapeutic, to the clinic for early stage Parkinson’s disease with the goal of a US FDA medical food regulatory status.

For additional information, please contact:
Mr. Robert Cervelli 902-222-4391 (cell) cervelli@neuroquest.ca
Dr. Bill Cheliak 613 240 5102 (cell) bcheliak@neurodyn.ca
Neurodyn Inc., Suite 508, NRC-INH, 550 University Avenue, Charlottetown PE C1A 4P3