|By PR Newswire||
|January 3, 2013 02:00 AM EST||
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. 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:
SOURCE Kareus Therapeutics
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
Feb. 20, 2017 04:00 AM EST Reads: 1,281
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 20, 2017 03:30 AM EST Reads: 6,125
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 20, 2017 03:15 AM EST Reads: 1,323
In today's uber-connected, consumer-centric, cloud-enabled, insights-driven, multi-device, global world, the focus of solutions has shifted from the product that is sold to the person who is buying the product or service. Enterprises have rebranded their business around the consumers of their products. The buyer is the person and the focus is not on the offering. The person is connected through multiple devices, wearables, at home, on the road, and in multiple locations, sometimes simultaneously...
Feb. 20, 2017 02:00 AM EST Reads: 6,079
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Feb. 20, 2017 02:00 AM EST Reads: 4,148
China Unicom exhibit at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE FDD, TD-LTE), fixed-line broadband, ICT, data communica...
Feb. 20, 2017 01:00 AM EST Reads: 825
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 20, 2017 01:00 AM EST Reads: 5,207
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Feb. 20, 2017 12:45 AM EST Reads: 2,389
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
Feb. 20, 2017 12:15 AM EST Reads: 960
As businesses adopt functionalities in cloud computing, it’s imperative that IT operations consistently ensure cloud systems work correctly – all of the time, and to their best capabilities. In his session at @BigDataExpo, Bernd Harzog, CEO and founder of OpsDataStore, will present an industry answer to the common question, “Are you running IT operations as efficiently and as cost effectively as you need to?” He will expound on the industry issues he frequently came up against as an analyst, and...
Feb. 20, 2017 12:00 AM EST Reads: 1,405
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Feb. 19, 2017 10:30 PM EST Reads: 6,149
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 19, 2017 09:30 PM EST Reads: 837
IoT offers a value of almost $4 trillion to the manufacturing industry through platforms that can improve margins, optimize operations & drive high performance work teams. By using IoT technologies as a foundation, manufacturing customers are integrating worker safety with manufacturing systems, driving deep collaboration and utilizing analytics to exponentially increased per-unit margins. However, as Benoit Lheureux, the VP for Research at Gartner points out, “IoT project implementers often un...
Feb. 19, 2017 08:00 PM EST Reads: 2,838
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Feb. 19, 2017 06:45 PM EST Reads: 3,155
SYS-CON Events announced today that IoT Now has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Feb. 19, 2017 06:15 PM EST Reads: 1,093