Kareus Therapeutics, a private biotechnology company focused on unmet treatment of age-related and chronic diseases, has initiated 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.

The Phase I clinical trial is a randomized, 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 in the U.S.

"We are excited to have obtained IND approval that will bring KU-046 into clinical development,” said Patrick Doyle, chief business and corporate development, Kareus Therapeutics. “This is a positive milestone, demonstrating the power of Kareus' innovation platform, which has already shown significant improvement in cognition in a number of pre-clinical models. We now believe we are well positioned to partner KU-046 to take it into the next stages of its development."

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.

Dr. Uday Saxena, chief R&D, Kareus Therapeutics, added, "The successful discovery of KU-046 has prompted us to use our bioenergetics and KARLECT platforms to discover drug candidates for other CNS diseases such as Parkinson's and Huntington's disease which have similar energy dysfunction."