Date: 2011-06-22
Type of information: Results
phase: 2b
Announcement: results
Company: Lipid Therapeutics (Germany)
Product: LT-02
Action
mechanism: LT-02 is a novel controlled release formulation of phosphatidylcholine specifically designed to treat ulcerative colitis by improving the barrier function of the mucosal layer of the colon.
Disease: ulcerative colitis
Therapeutic area: Inflammatory diseases - Autoimmune diseases
Country: Germany, Lithuania, Romania
Trial
details: 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.
Latest
news: Lipid Therapeutics has announced positive topline results from a Phase IIb clinical trial with its lead product, LT-02, in patients with ulcerative colitis. 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.
Lipid Therapeutics intends to present full data on the trial at UEGW in Stockholm in October 2011. The company will now discuss with its European partner, Dr. Falk Pharma, and with potential partners in the US and Japan how it can rapidly move this innovative therapeutic into a pivotal Phase III study.
