Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Esmeralda Swartz, Hovhannes Avoyan, Elizabeth White, Adrian Bridgwater

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
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The best mobile applications are augmented by dedicated servers, the Internet and Cloud services. Mobile developers should focus on one thing: writing the next socially disruptive viral app. Thanks to the cloud, they can focus on the overall solution, not the underlying plumbing. From iOS to Android and Windows, developers can leverage cloud services to create a common cross-platform backend to persist user settings, app data, broadcast notifications, run jobs, etc. This session provide...
SYS-CON Events announced today that Soha will exhibit at SYS-CON's DevOps Summit New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Soha delivers enterprise-grade application security, on any device, as agile as the cloud. This turnkey, cloud-based service enables customers to solve secure application access and delivery challenges that traditional or virtualized network solutions cannot solve because they are too expensive, inflexible and operational...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch ...
Health care systems across the globe are under enormous strain, as facilities reach capacity and costs continue to rise. M2M and the Internet of Things have the potential to transform the industry through connected health solutions that can make care more efficient while reducing costs. In fact, Vodafone's annual M2M Barometer Report forecasts M2M applications rising to 57 percent in health care and life sciences by 2016. Lively is one of Vodafone's health care partners, whose solutions enable o...
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will mee...
of cloud, colocation, managed services and disaster recovery solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. TierPoint, LLC, is a leading national provider of information technology and data center services, including cloud, colocation, disaster recovery and managed IT services, with corporate headquarters in St. Louis, MO. TierPoint was formed through the strategic combination of some of t...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of C...
Public Cloud IaaS started it's life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in ado...
Dave will share his insights on how Internet of Things for Enterprises are transforming and making more productive and efficient operations and maintenance (O&M) procedures in the cleantech industry and beyond. Speaker Bio: Dave Landa is chief operating officer of Cybozu Corp (kintone US). Based in the San Francisco Bay Area, Dave has been on the forefront of the Cloud revolution driving strategic business development on the executive teams of multiple leading Software as a Services (SaaS) ap...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
ProfitBricks, the provider of painless cloud infrastructure IaaS, today released its SDK for Ruby, written against the company's new RESTful API. The new SDK joins ProfitBricks' previously announced support for the popular multi-cloud open-source Fog project. This new Ruby SDK, which exposes advanced functionality to take advantage of ProfitBricks' simplicity and productivity, aligns with ProfitBricks' mission to provide a painless way to automate infrastructure in the cloud. Ruby is a genera...
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Compa...
ProfitBricks, the provider of painless cloud infrastructure for IaaS, today announced the release of a Node.js SDK written against its recently launched REST API. This new JavaScript based library provides coverage for all existing ProfitBricks REST API functions. With additional libraries set to release this month, ProfitBricks continues to prove its dedication to the DevOps community and commitment to making cloud migrations and cloud management painless. Node.js is an open source, cross-pl...