FDA Approves NeuroGenetic Pharmaceuticals' IND Application for Alzheimer’s Drug

Sep 30, 2014

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD). The approval follows successful completion of all preclinical phases under a fast-track grant from the National Institute of Neurologic Disease and Stroke (NINDS), according to a NGP press release.

Dr. William T. Comer, CEO of NGP, a privately held biopharmaceutical company focused on Alzheimer’s disease therapeutics, said NGP completed pre-clinical toxicology and safety studies of NGP 555 under Small Business Innovation Research (SBIR) grants from the NINDS. The efficacy studies showed beneficial and chronic effects on amyloid biomarkers, pathology and cognition while lacking the side effects of other compounds and mechanisms for preventing Alzheimer’s disease (AD).

“NGP 555 prevented the formation of and the deposition of amyloid plaques, thereby precluding neuronal cell death and the dementia associated with AD,” said Comer.

Comer said NGP anticipates it will begin Phase I human clinical trials by the end of 2014. Read the full release