FDA accepts IND application to initiate human clinical trial to evaluate BNC

Dec 3 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC). "Receiving clearance to move into clinical studies for BNC is a significant milestone for QR Pharma," said Maria Maccecchini, CEO of QR Pharma.

“Receiving clearance to move into clinical studies for BNC is a significant milestone for QR Pharma”

BNC was discovered by Dr. Nigel Greig in his laboratory at the National Institutes of Health/National Institute on Aging (NIH/NIA). The compound targets AD via selective butyrylcholinesterase inhibition (BChEI) as well as with a disease modifying activity via amyloid precursor protein (APP) inhibition. All preclinical in vitro and in vivo work for BNC - toxicology, pharmacokinetics (PK) and pharmacodynamics (PD) - has been completed. BNC was found to be safe and have excellent half-life. It has an interesting preclinical profile making it suitable for clinical development in patients suffering from AD and dementia.

Since BChE is elevated in advanced AD patients, studies suggest that the compound may improve cognition in later stage AD patients. BNC complements the lead compound, Posiphen®, which is intended to treat mild cognitive impaired and early AD patients. BNC provides a unique opportunity to improve on existing cholinesterase inhibition and marry improvements in cognition to slowing of the disease to obtain a better outcome for AD.