The FDA has approved Neuronascent’s investigational new drug (IND) application for NNI-362—their therapy candidate for Alzheimer’s disease. The sponsor will commence with a Phase 1a clinical trial. They will evaluate the safety of NNI-362 in healthy volunteers, ages 50-72. The study will be run a single clinical site. The research team is planning on recruiting 56 healthy older participants.
About the Sponsor: Neuronascent, Inc.
Neuronascent Inc. is developing disease modifying therapeutics for some of the most difficult to treat brain disorders that include Alzheimer’s disease, Parkinson’s disease and Down syndrome. Founded in 2004 according to CrunchBase they have raised $1.3 million.
Their lead candidate NNI-362 not only shows efficacy, by increasing the number of new neurons that survive to maturity that is associated with a reversal in behavior impairment, but is also shown to be safe in all FDA required GLP safety tests according to their website.
Dr. Scott R. Turner, MD, PhD, director of the Memory Disorders Program, Georgetown University