The primary endpoints have been met in a clinical trial of a drug for patients suffering from ulcerative colitis.
, a biotechnology company focused on novel treatments for inflammatory bowel disease (IDB), has publicized that the primary endpoints have been met in a Phase IIb clinical trial of its lead product for patients suffering from ulcerative colitis.
The product, 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,” wrote Lipid Therapeutics.
The study was conducted by Max Karner MD, of the University Clinic Heidelberg in Germany.
The clinical trial was a double-blind, randomized, multi-center, parallel group, placebo-controlled, dose ranging study, the purpose of which was to explore the efficiency and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.
156 patients participated in the trial at one of twenty-four centers located in Germany, Lithuania, and Romania. Patients were treated for twelve weeks and were randomly selected to receive one of three doses of LT-02 or a placebo.
The primary endpoint which was met in the Phase IIb trial was change in Simple Clinical Colitis Activity Index (SCCAI); this goal was achieved in patients who were unresponsive to standard first-line intervention by administering them 0.8g of LT-02 four times per day. This action showed a 51% reduction of ulcerative colitis symptoms in patients who received the LT-02 in comparison to a 33% reduction in patients who received a placebo.
Positive results were also seen in patients who received one of two lower doses of LT-02.
Karner stated, “The positive clinical results that we have seen with patients treated with LT-02 clearly suggests that it has the potential to become a very attractive new treatment option for patients with ulcerative colitis who currently have limited options.”
CEO of Lipid Therapeutics, Dr. Gerhard Keilhauer, reported, “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,” Keilhauer concluded.
Lipid Therapeutics intends to present full data on the trial at United European Gastroenterology Federation in Stockholm in October 2011.