Kareus Therapeutics Announces Phase I Trial for Product in Alzheimer's Disease

LA CHAUX-DE-FONDS, Switzerland, January 3, 2013 /PRNewswire/ --

~ Following US IND approval, Phase I trial to assess safety, tolerability and pharmacokinetics of KU-046 in healthy young volunteers ~

Kareus Therapeutics SA ("Kareus" or the "Company"), the private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, today announces 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 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, the world's leading biopharmaceutical service provider, at its Phase I Unit at Overland Park in Kansas, US.

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.  

Commenting on the news, 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."  

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."

About Kareus Therapeutics SA

Kareus Therapeutics SA is a private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases. Kareus' pipeline consists of pre-clinical stage assets in Alzheimer's, Metabolic Diseases, Pain & Inflammation, where the company employs two different approaches to drug discovery and development: i) KARLECT, a unique enabling chemistry platform that combines currently marketed drugs and GRAS molecules to produce new chemical entities for CNS disorders, and ii) novel small molecule drug discovery in metabolic diseases, pain & inflammation. Kareus' business strategy is to form strategic alliances with leading pharmaceutical companies, which have the complementary skills to maximize the business and therapeutic potential of its molecules. In June 2011, Kareus entered into a strategic drug development alliance with Quintiles to progress the development of two of Kareus' pre-clinical programs (Alzheimer's & Type-2 diabetes) through clinical trials.

For further information, please visit http://www.kareustherapeutics.com.

About Alzheimer's disease

Alzheimer's disease, the most common form of dementia, causes a progressive decline in memory and other aspects of cognition. It is unknown what causes Alzheimer's disease and there are currently no approved treatments shown to slow the progression of the disease. Alzheimer's Disease International (ADI) estimates that there are currently over 36 million people with dementia worldwide, with 7.7 million new cases each year, or one new case every four seconds.^[1] The number of people affected is estimated to be over 115 million by 2050 Alzheimer’s Disease International. World Alzheimer Report 2009. London : Alzheimer’s Disease International, 2009.

About Investigational New Drug Application (IND)

IND is an application that a drug sponsor must submit to U.S. Food and Drug Administration (FDA) before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test results, and manufacturing information. The equivalent in Europe is called an Investigational Medicinal Product Dossier (IMPD).

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1. World Health Organization. Dementia: a public health priority. Geneva : World Health Organization, 2012. ISBN 978-92-4-156445-8.

For more information, please contact:

Kareus Therapeutics
Patrick Doyle
T: +44(0)7871-309-056
E: pdoyle@kareustherapeutics.com

M:Communications
Claire Dickinson
T: +44(0)20-7920-2360
E: kareus@mcomgroup.com