Date: 2014-09-29
Type of information: Clinical trial autorization
phase:
Announcement: clinical trial authorisation
Company: NeuroGenetic Pharmaceuticals (USA - CA)
Product: NGP 555
Action
mechanism: NGP 555 is a gamma-secretase modulator (GSM) demonstrating good brain penetration and targeting the gamma-secretase complex, a key enzyme in the amyloid pathway.
Disease: Alzheimer’s disease
Therapeutic area: Neurodegenerative diseases
Country:
Trial details:
Latest
news: * On September 29, 2014, the FDA has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease. 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, said the company 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. NGP anticipates it will begin Phase I human clinical trials by the end of 2014.
