SAN DIEGO--(BUSINESS WIRE)--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).
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, grant no. 1U44NS073133-01A1 totaling $3.4 million. 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.
NGP 555, a proprietary “first in class” molecule for the treatment/prevention of Alzheimer’s disease, is a gamma-secretase modulator (GSM) demonstrating good brain penetration and targeting the gamma-secretase complex, a key enzyme in the amyloid pathway. A novel solid dosage form in capsules is available for once daily oral dosing, Comer said.
Comer said NGP anticipates it will begin Phase I human clinical trials by the end of 2014.
About NeuroGenetic Pharmaceuticals, Inc.
NeuroGenetic Pharmaceuticals, Inc. (NGP), San Diego, is a biopharmaceutical discovery and development company founded in 2009 to develop innovative drug therapies for Alzheimer’s disease. NGP 555 is its first compound approved by the FDA to enter clinical trials.
About Alzheimer’s disease
Alzheimer’s disease is a progressive and fatal brain disease with 5.5 million Americans and up to 30 million worldwide currently living with the disease. The NIH reports that unless the disease can be effectively prevented, the number of people with AD will increase significantly. The FDA acknowledges that advanced stages of Alzheimer’s dementia cannot be treated effectively, and the cognitive impairment must be diagnosed early before the amyloid plaques are well developed. The disease must be prevented, and recent efforts have focused on early diagnosis of amyloid deposits and cognitive impairment so that a drug like NGP 555 can be taken early in the course of the disease and retard the course of disease.