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news.The US Food and Drug Administration (FDA) has accepted QR Pharma's investigational new drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).
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The compound targets AD via selective butyrylcholinesterase inhibition (BChEI) as well as with a disease modifying activity via amyloid precursor protein (APP) inhibition.
QR Pharma has completed all preclinical in-vitro and in-vivo work- toxicology, pharmacokinetics (PK) and pharmacodynamics (PD) for BNC.
In the trial, BNC was found to be safe and have half-life.
Since BChE is elevated in advanced AD patients, studies suggest that the compound may improve cognition in later stage AD patients.
QR Pharma claims BNC provides an opportunity to improve on existing cholinesterase inhibition and marry improvements in cognition to slowing of the disease to obtain a better outcome for AD.
QR Pharma CEO Maria Maccecchini said receiving clearance to move into clinical studies for BNC is a significant milestone for the company.