|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.
SOURCE Kareus Therapeutics
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Dec. 2, 2016 01:30 PM EST Reads: 5,683
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...
Dec. 2, 2016 01:30 PM EST Reads: 1,801
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 2, 2016 01:15 PM EST Reads: 2,066
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Dec. 2, 2016 01:00 PM EST Reads: 1,375
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Dec. 2, 2016 01:00 PM EST Reads: 2,437
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Dec. 2, 2016 12:11 PM EST Reads: 179
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
Dec. 2, 2016 12:00 PM EST Reads: 1,823
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 2, 2016 12:00 PM EST Reads: 146
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 2, 2016 11:45 AM EST Reads: 1,451
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and G...
Dec. 2, 2016 11:30 AM EST Reads: 1,844
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 2, 2016 11:30 AM EST Reads: 3,737
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 2, 2016 11:00 AM EST Reads: 396
"Qosmos has launched L7Viewer, a network traffic analysis tool, so it analyzes all the traffic between the virtual machine and the data center and the virtual machine and the external world," stated Sebastien Synold, Product Line Manager at Qosmos, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 2, 2016 11:00 AM EST Reads: 394
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 2, 2016 10:45 AM EST Reads: 1,592
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 2, 2016 10:30 AM EST Reads: 1,897