Click here to close now.


News Feed Item

Lipid Therapeutics Successfully Files a US IND for LT-02, a Novel Barrier Function Therapy for Ulcerative Colitis

HEIDELBERG, Germany, April 10, 2013 /PRNewswire/ --

IND paves the way for the US element of a global Phase III development program with LT-02 in conjunction with European licensee Dr. Falk Pharma GmbH, whose pivotal study will start in Q4 2013

Lipid Therapeutics announces today that it has successfully filed its first US IND for its lead product LT-02 and is now in a position to proceed with a planned Phase III trial in the US in mild-moderate ulcerative colitis patients. The LT-02 IND was subject to the FDA's customary 30 day review period.

Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, commented: "We are very pleased to have cleared this important regulatory milestone that paves the way for late-stage development of LT-02 in the US. The strong safety record of our oral phospholipid active ingredient has allowed us to move forward without the need for further non-clinical toxicology or additional human safety studies."  

The Phase III trials in the US and Europe will be conducted as part of a synchronized global pivotal plan and are expected to begin in Q4 2013. Lipid Therapeutics intends to conduct the US portion of the program with a partner, in parallel with the trials to be conducted in Europe by Lipid Therapeutics' European licensee for LT-02, Dr. Falk Pharma GmbH. The combined clinical program will involve over 700 patients in each of two induction studies, with the objective of achieving remission based on the primary endpoint of reducing the patient's Mayo Score. The two induction trials will be followed by a single global maintenance trial.

In the planned global Phase III program LT-02 will be tested as add-on therapy to mesalazine. This is a significant area of high unmet medical need as approximately 40% of patients receiving the maximum dose of mesalazine, the standard 1st line therapy for ulcerative colitis, continue to experience flares of disease activity and therefore require additional treatment.

About Ulcerative Colitis

Ulcerative colitis is a chronic, relapsing inflammatory disorder that affects the mucosal lining of the large intestine. Clinical characteristics include rectal bleeding, diarrhea and abdominal pain. Worldwide more than 1 million people suffer from ulcerative colitis.

About LT-02

LT-02 is a first-in-class highly purified phosphatidylcholine targeted to improve the barrier function in the colon through a proprietary delayed release formulation. Loss of barrier function in the colon in patients with ulcerative colitis has been linked to inflammation due to prolonged bacterial contact with the gut mucosa. A Phase IIb trial conducted in Europe met its primary endpoint (reduction of disease activity in patients with mesalazine-refractory ulcerative colitis) with statistical significance, following which Dr. Falk converted its option on the product to a license agreement for the European territories.

About Lipid Therapeutics

Lipid Therapeutics is a biopharmaceutical company focused on the development and commercialization of phospholipids. The company was founded in 2008 by the EMBL Technology Fund to commercialize the scientific work of Prof. Wolfgang Stremmel, Krehl University Clinic in Heidelberg, Germany.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH is one of the most recognized companies worldwide in gastroenterology. Dr. Falk Pharma GmbH products are sold in more than 60 countries. The Falk Foundation, which is associated with the company, provides medical information via international symposia, forums, postgraduate courses and literature services. Over the past 45 years the Falk Foundation has sponsored more than 200 international Falk symposia and workshops in which over 100,000 researchers and physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology.

Contact for Lipid Therapeutics GmbH:
Dr. Gerhard Keilhauer
Phone: +49-6221-3350581
Email: [email protected]

Contact Citigate Dewe Rogerson:
Sita Shah/Chris Gardner
Phone: +44-(0)20-7282-1052
Email: [email protected]/[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
Docker is hot. However, as Docker container use spreads into more mature production pipelines, there can be issues about control of Docker images to ensure they are production-ready. Is a promotion-based model appropriate to control and track the flow of Docker images from development to production? In his session at DevOps Summit, Fred Simon, Co-founder and Chief Architect of JFrog, will demonstrate how to implement a promotion model for Docker images using a binary repository, and then show h...
As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ability. Many are unable to effectively engage and inspire, creating forward momentum in the direction of desired change. Renowned for its approach to leadership and emphasis on their people, organizations increasingly look to our military for insight into these challenges.
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively.
DevOps and Continuous Delivery software provider XebiaLabs has announced it has been selected to join the Amazon Web Services (AWS) DevOps Competency partner program. The program is designed to highlight software vendors like XebiaLabs who have demonstrated technical expertise and proven customer success in DevOps and specialized solution areas like Continuous Delivery. DevOps Competency Partners provide solutions to, or have deep experience working with AWS users and other businesses to help t...
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, foc...
Nowadays, a large number of sensors and devices are connected to the network. Leading-edge IoT technologies integrate various types of sensor data to create a new value for several business decision scenarios. The transparent cloud is a model of a new IoT emergence service platform. Many service providers store and access various types of sensor data in order to create and find out new business values by integrating such data.
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....
Containers are changing the security landscape for software development and deployment. As with any security solutions, security approaches that work for developers, operations personnel and security professionals is a requirement. In his session at @DevOpsSummit, Kevin Gilpin, CTO and Co-Founder of Conjur, will discuss various security considerations for container-based infrastructure and related DevOps workflows.
The cloud has reached mainstream IT. Those 18.7 million data centers out there (server closets to corporate data centers to colocation deployments) are moving to the cloud. In his session at 17th Cloud Expo, Achim Weiss, CEO & co-founder of ProfitBricks, will share how two companies – one in the U.S. and one in Germany – are achieving their goals with cloud infrastructure. More than a case study, he will share the details of how they prioritized their cloud computing infrastructure deployments ...
Chris Van Tuin, Chief Technologist for the Western US at Red Hat, has over 20 years of experience in IT and Software. Since joining Red Hat in 2005, he has been architecting solutions for strategic customers and partners with a focus on emerging technologies including IaaS, PaaS, and DevOps. He started his career at Intel in IT and Managed Hosting followed by leadership roles in services and sales engineering at Loudcloud and Linux startups.
There are so many tools and techniques for data analytics that even for a data scientist the choices, possible systems, and even the types of data can be daunting. In his session at @ThingsExpo, Chris Harrold, Global CTO for Big Data Solutions for EMC Corporation, will show how to perform a simple, but meaningful analysis of social sentiment data using freely available tools that take only minutes to download and install. Participants will get the download information, scripts, and complete en...
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing thes...
Between the compelling mockups and specs produced by analysts, and resulting applications built by developers, there exists a gulf where projects fail, costs spiral, and applications disappoint. Methodologies like Agile attempt to address this with intensified communication, with partial success but many limitations. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a revolutionary model enabled by new technologies. Learn how busine...