Date: 2013-01-03
Type of information:
phase: 1
Announcement: initiation of the study
Company: Kareus Therapeutics (Switzerland)
Product: KU-046
Action
mechanism: Kareus has developed a pipeline of novel molecules targeting diseases of the central nervous system based on its proprietary KARLECT chemistry and drug discovery platforms which target dysfunctional energy production in neurons. KU-046 targets bioenergetics pathways upstream from the increased abeta peptide production found in Alzheimer’s disease. It has demonstrated significant improvement in cognition in a number of pre-clinical models.
Disease: Alzheimer’s disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: The Phase I clinical trial is a randomised, double-blind, placebo-controlled two-part study to assess the safety, tolerability and pharmacokinetics of single ascending oral doses and of multiple ascending oral doses of KU-046 in 54 healthy young volunteers. The study is being conducted by Quintiles, at its Phase I Unit at Overland Park in Kansas, US. Quintiles and Kareus Therapeutics have concluded a broad strategic alliance in June 2011. The agreement aimed to progress the development of two of Kareus\' pre-clinical programs (KU-046 and a diabetes candidate) through clinical trials.
Latest
news: Kareus Therapeutics, a biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, has announced the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the FDA for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer’s disease using Kareus’ proprietary bioenergetics and KARLECT platforms.
