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Lipid Therapeutics: Primary endpoint met with LT-02 / Phase IIb in patients with ulcerative colitis

22-06-2011. Lipid Therapeutics, a biotechnology company focused on novel treatments for inflammatory bowel disease, today announced positive topline results from a Phase IIb clinical trial with its lead product, LT-02, in patients with ulcerative colitis. LT-02 is a controlled release formulation of phosphatidylcholine that has been specifically designed to treat ulcerative colitis by improving the barrier function of the mucosal layer of the colon, a concept that has now been successfully tested in several clinical trials.


The Phase IIb trial met the primary end point, change in  SCCAI (Simple Clinical Colitis Activity Index), for patients refractory to standard first-line intervention who were treated with LT-02 at 0.8g four times a day (51% reduction with LT-02 vs 33% reduction with placebo; p <0.05). Patients who received one of two lower doses of LT-02 also showed a positive benefit. The excellent safety profile of LT-02 treatment was comparable to placebo at all three doses. The Phase IIb trial was a randomized, multi-center, double-blind, parallel group, placebo-controlled, dose ranging study that was designed to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. 156 patients were enrolled into the trial at 24 centers in Germany, Lithuania and Romania. Patients were randomized to receive one of three doses of LT-02 or placebo and were treated for a period of 12 weeks.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, said: “The results that we have announced today are a key milestone for Lipid Therapeutics. We are delighted that LT-02, which has a novel mode of action, has been shown to be of significant benefit to patients with ulcerative colitis whose condition has not responded to the current mainstay of therapy, i.e. mesalazine. We will now discuss with our European partner, Dr. Falk Pharma, and with potential partners in the US and Japan how we can rapidly move this innovative therapeutic into a pivotal Phase III study, the next key step in making it available to ulcerative colitis patients as quickly as possible.”


LT-02 is a novel controlled release formulation of phosphatidylcholine that augments the natural protective mucosal barrier in the lower gut. It is the first product candidate worldwide that targets the pathological changes in the lower gut barrier function of colitis patients which are thought to be one of the main underlying disease causes.

 

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Background

by B2Bioworld Editor*

 

Lipid Therapeutic GmbH’s drug candidate is based on the work of Prof. Dr. Walter Stremmel, Medical Director at Transplant Centre Surgery, Universitätsklinikum Heidelberg (DE) and his collaborators. Dr. Stremmel discovered that inflammatory, ischemic or degenerative disorders (in particular liver diseases) could be treated with lysophosphatidylethanolamine coupled to ursodeoxycholate which is converted to a ester LysoPE-DOCA. In ulcerative colitis the lack of phosphatidylcholine in the colonic mucus is hypothesized to cause the disease. The current trial aims to study the effects of a retarded release preparation of phosphatidylcholine on restoring the mucosal barrier function.

In addition to ulcerative colitis LT-02 is under study for conditions of abdominal pain, diarrhea, and large intestine.

 

The therapeutically active lipid Ursodeoxycholate, a LysoPE conjugate:

 

Source: Stemmler, US0166401, 10-07-2008.

 

In an interview (in German) Dr. Stremmel details the treatment. The non-dated interview is published by Heidelberg University Clinic and targeted to the general public resp. patients interested to participate in the clinical trial.

 

 

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