Why Can’t We Just Produce New Brain Neurons and Reverse Neurodegenerative Disease?-Judith Kelleher-Andersson-05/16/2017 - 8:30am

Event Information
Event Topic: 
Why Can’t We Just Produce New Brain Neurons and Reverse Neurodegenerative Disease?
Event Date: 
05/16/2017 - 8:30am
Event Location: 
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale
Speaker Information
Event Speaker: 
Judith Kelleher-Andersson
Event Speaker Title: 
Founder, President and CEO
Event Speaker Company: 
Neuronascent, Inc.
Event Speaker Bio: 

Judith Kelleher-Andersson, Ph.D., Founder, President and CEO

Dr. Kelleher-Andersson has over twenty years of experience discovering and developing small molecule, central nervous system therapeutics in the biotechnology industry. She has raised equity of over 2 million and obtained a number of state and federal grants related to novel therapeutic development. After founding Neuronascent, Kelleher-Andersson discovered and developed a number of technologies. One lead therapeutic is a first-in-class neuron regenerative agent, that is patented and has competed all GLP safety testing, GMP manufacturing and brings the lead to point of IND application to begin first-in-human testing in healthy aged population.
Prior to founding Neuronascent, Inc, she directed drug development research at Neuralstem, Inc., at Centaur Pharmaceuticals and at Cortex Pharmaceuticals, Inc. She strategically directed research/development and personnel toward finding innovative therapies for neurological indications with large unmet need. She headed the Alzheimer’s disease program in collaboration with Astra-Zeneca while at Centaur, and successfully brought a small molecule therapeutic to pre-nomination status (primary inventor). She is primary inventor on a neurogenic depression therapeutic, while at Neuralstem, that is presently in Phase 2b clinical testing. Dr. Kelleher-Andersson has over 70 US, European and World patents. She received her Ph.D. in biochemistry from the University of Missouri-Columbia and completed post-graduate work at University of California, Los Angeles and at University of California, San Francisco.

Event Details
Event Details: 

There is only marginal, symptomatic relief for the approximately 5.3 million Americans thought to already suffer from Alzheimer's disease (AD). With a decade of failures for neuroprotective agents alone, Neuronascent discovered and developed a therapy that would not just stop further neuron loss and dysfunction, but that would promote new neurons that survive to maturation, replacing those lost. This first-in-class, neuron regenerative agent should then halt or even reverse the memory impairment in Alzheimer's patients. The unique mechanism of action was only determined after the identification of a lead candidate through a phenotypic
screening platform and optimization program. Neuronascent aims to submit an IND to the FDA for NNI-362 for Alzheimer's disease in 2017. The NIA supported a pre-IND meeting with the FDA and supported all of the FDA-required GLP safety studies showing the agent to be safe. On obtaining FDA approval to initiate the first-in-human testing of NNI-362 for Alzheimer's disease, Neuronascent aims to determine the safety, tolerability and PK in a healthy volunteers aged 50-72. Male and female volunteers will be administered a single dose of NNI-362 orally at one of three ascending doses (SAD) , with and without food. This will be followed by a 14-day daily ascending dose (MAD) test. Plasma levels of NNI-362 will be assessed to determine pharmacokinetics and whether a pharmacodynamic dose has potentially been reached. If NNI-362 is deemed safe and well-tolerated, the agent could then be tested for ability to promote new neurons and halt or reverse cognitive deficits and reverse impaired function in Alzheimer's patients in POC trials.