Kareus Therapeutics SA has announced the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration 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 at its Phase I Unit at Overland Park in Kansas.
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.
Dr. Uday Saxena, Chief Research and Development at Kareus Therapeutics, commented, "Achieving our objective to reach IND approval for KU-046 within threeyears and in a cost-efficient manner is strong testament to the commitment and hard work of our team." He added: "Alzheimer's disease is the most common form of dementia which affects over 35 million people worldwide and for which there are currently no disease modifying approved treatments. We are therefore hugely excited and encouraged by the potential of KU-046 to treat patients with this devastating condition. The successful discovery of KU-046 has prompted us to use our bioenergetics and KARLECT platformsto discover drug candidates for other CNS diseases such as Parkinson's and Huntington's disease which have similar energy dysfunction."
Patrick Doyle, Chief Business and Corporate Development at Kareus Therapeutics, said, "We are excited to have obtained IND approval that will bring KU-046 into clinical development. 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." He added: "We now believe we are well positioned to partner KU-046 to take it into the next stages of its development."