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LT-02 begins phase 3 trial for treatment of ulcerative colitis
The first patients have been enrolled into a phase 3 trial of LT-02, a delayed release form of phosphatidylcholine, for patients with mild to moderate ulcerative colitis who are not responding to treatment with 5-aminosalicylic acid, according to a press release from Lipid Therapeutics.
The trial has begun in Europe through Lipid Therapeutics’ partner Dr. Faulk Pharma GmbH. Based on positive feedback from the FDA, more than 500 patients in the United States will be enrolled in a phase 3 trial of the drug with the goal of achieving remission, defined as a meaningful reduction in the Mayo Disease Activity Score as the target endpoint.
The drug is designed to be an added treatment for those taking 5-aminosalicylic acid (5-ASA) to improve the barrier function of the mucosal layer of the colon.
About 760 patients are expected to be enrolled in the randomized, double blind, placebo-controlled trial in Europe
“The start of this pivotal phase 3 with LT-02 in Europe is a major step in the further development of this new oral phospholipid drug for UC,” Ursula Falk, CEO of Dr. Falk Pharma, said in the press release. “If successful, we believe that LT-02 could become an important treatment option for patients around the world who are poorly served by existing therapies.”
“We are confident that the inclusion of patients from both Europe and the US will enable us to generate significant clinical data showing that LT-02 delivers improved outcomes for patients with UC,” Gerhard Keilhauer, PhD, CEO of Lipid Therapeutics, said in the release.