Welcome!

News Feed Item

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).

--------------------------------------------------

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: [email protected]

M:Communications
Claire Dickinson
T: +44(0)20-7920-2360
E: [email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
"We're developing a software that is based on the cloud environment and we are providing those services to corporations and the general public," explained Seungmin Kim, CEO/CTO of SM Systems Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
"CA has been doing a lot of things in the area of DevOps. Now we have a complete set of tool sets in order to enable customers to go all the way from planning to development to testing down to release into the operations," explained Aruna Ravichandran, Vice President of Global Marketing and Strategy at CA Technologies, in this SYS-CON.tv interview at DevOps Summit at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Infoblox does DNS, DHCP and IP address management for not only enterprise networks but cloud networks as well. Customers are looking for a single platform that can extend not only in their private enterprise environment but private cloud, public cloud, tracking all the IP space and everything that is going on in that environment," explained Steve Salo, Principal Systems Engineer at Infoblox, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventio...
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...
"Codigm is based on the cloud and we are here to explore marketing opportunities in America. Our mission is to make an ecosystem of the SW environment that anyone can understand, learn, teach, and develop the SW on the cloud," explained Sung Tae Ryu, CEO of Codigm, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...