Phase III studies with delayed-release phosphatidylcholine are expected to start this year.
Lipid Therapeutics licensed European rights to its lead Phase III-ready ulcerative colitis (UC) candidate, LT-02, to Dr. Falk Pharma. The deal follows on from a co-development and option agreement signed in 2009, and will see Dr. Falk take over full responsibility for the further development and commercialization of LT-02 in Europe. In return Lipid will receive an up-front fee, milestones, and royalties. A Phase III induction trial is expected to start during the second half of 2012. Lipid says it is in discussions with potential U.S. development partners for the drug.
LT-02 is a delayed-release formulation of phosphatidylcholine, which is designed to target pathological changes in the mucosal barrier of the lower gut, which are believed to be one of the primary causes of ulcerative colitis. Positive data from a Phase II European study with LT-02 will be presented at the “Digestive Disease Week” conference in San Diego in May.
“Our agreement with Dr. Falk Pharma is an important step toward bringing LT-02 to patients suffering from UC,” comments Gerhard Keilhauer, Ph.D., Lipid’s CEO. “Lipid Therapeutics is now preparing to meet with FDA to agree on a coordinated development pathway in the U.S. and EU.”
Heidelberg-based Lipid Therapeutics was established in 2008 by the EMBL Technology Fund, to develop therapies for inflammatory diseases of the digestive system. The company’s current focus is continued development of LT-02, based on preclinical and clinical work conducted by researchers at University Hospital Heidelberg.