Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Lipid Therapeutics Successfully Files a US IND for LT-02

Published: Thursday, April 11, 2013
Last Updated: Thursday, April 11, 2013
Bookmark and Share
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 has announced 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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More Than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Lipid Therapeutics Licenses Rights to UC Therapy to Nestlé Health Science
Lipid Therapeutics has announced that it has entered into a licensing agreement with Nestlé Health Science for exclusive rights to Lipid Therapeutics’ LT-02 compound a novel barrier function therapy for patients with mild-to-moderate ulcerative colitis.
Monday, September 21, 2015
Lipid Therapeutics Enters Licensing Agreement with Nestlé Health Science
Nestlé Health Science to develop and commercialize LT-02 worldwide, except in Europe and Australia.
Thursday, September 17, 2015
Dr. Falk Pharma GmbH Enrolls First Patients into Pivotal Phase III Trial with LT-02
Positive FDA feedback on the protocol for the US Phase III trial with LT-02, a key element of the product’s global development program.
Saturday, November 01, 2014
Lipid Therapeutics Licenses European Rights to LT-02 for Ulcerative Colitis
Dr. Falk Pharma GmbH to initiate Phase III trial.
Friday, March 09, 2012
Scientific News
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
The Rise of 3D Cell Culture and in vitro Model Systems for Drug Discovery and Toxicology
An overview of the current technology and the challenges and benefits over 2D cell culture models plus some of the latest advances relating to human health research.
Study Identifies How Brain Connects Memories Across Time
UCLA Neuroscientists have boost ability of aging brain to recapture links between related memories.
3-D Atomic Structure of Cholesterol Transporter
Researchers at UTSW have determined the 3-D atomic structure of a human sterol transporter that helps maintain cholesterol balance.
First Large-Scale Proteogenomic Study of Breast Cancer
The study offers understanding of potential therapeutic targets.
Can We Break the Link Between Obesity and Diabetes?
Columbia University researchers identify a key molecule involved in the development of type 2 diabetes.
Fungi – A Promising Source Of Chemical Diversity
Moulds and plants share similar ways in alkaloid biosynthesis .
How Prions Kill Neurons: New Culture System Shows Early Toxicity to Dendritic Spines
Boston University researchers have developed a cell culture system to study prions.
Great Migration and African-American Genomic Diversity
Study examines genetic data to analyze regional differences in ancestry.
Faster, More Efficient CRISPR Editing
UC Berkeley scientists have developed a quicker and more efficient method to alter the genes of mice with CRISPR-Cas9, simplifying a procedure growing in popularity because of the ease of using the new gene-editing tool.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!