Date: Sep 29, 2014 Author: Neurogenetic Pharmaceuticals Source: Company Data (
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SAN DIEGO, Sept. 29, 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).
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.
