FDA Endorses Further Studies on Ulcerative Colitis Drug from Lipid Therapeutics

FDA Endorses Further Studies on Ulcerative Colitis Drug from Lipid Therapeutics

shutterstock_128571422Biopharmaceutical company Lipid Therapeutics has just announced the successful enrollment of the first batch of participants in a Phase III clinical trial for LT-02, the company’s first-in-class highly purified phosphatidylcholine pipeline product indicated for the treatment of ulcerative colitis that works to improve colon barrier function with delayed release technology. Dr. Falk Pharma GmbH is the company’s co-development partner in Europe, and will be overseeing the clinical research for this initial group of patients.

Lipid Therapeutics also revealed the US Food and Drug Administration has endorsed its Phase III procedure, allowing the company to proceed with a 500-patient study in the US. This trial’s main goal is to induce remission and measure its significance with a reduction of the Mayo Disease Activity Score in participants. Together with the European Phase III trial led by Dr. Falk Pharma, Lipid Therapeutics is well on its way to gathering substantial clinical evidence for the soonest approval of LT-02 in both territories.

“The start of this pivotal Phase III with LT-02 in Europe is a major step in the further development of this new oral phospholipid drug for UC. In the US, the positive advice from the FDA means that Lipid Therapeutics is well placed to advance its preparations for a parallel pivotal Phase III trial. 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.” – Ursula Falk, Chief Executive Officer of Dr. Falk Pharma GmbH

This novel drug employs phosphatidylcholine in a delayed release formulation to supplement treatment with 5-ASA. Today, the need for safer and more effective treatments for ulcerative colitis remains unmet, leaving UC patients with few treatment options aside from the standard mesalazine, which has been observed to still cause symptom flare ups in about 40 percent of patients. This prompts additional treatment with steroids and other biologicals, making living with this chronic disease costly and unpredictable.

“Dr. Falk Pharma has proved to be a very capable partner, having moved LT-02 into a pivotal Phase III trial in Europe, said Dr. Gerhard Keilhauer, Chief Executive Officer of Lipid Therapeutics. “We are very pleased with the positive feedback from the FDA on our development plans for LT-02 in the US. 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.”

The European LT-02 clinical trial aims to determine the effectiveness and safety of the drug when used as an adjunctive treatment in UC patients reported to be minimally or not responsive to treatment with mesalamine. Other research goals are evaluating LT-02’s tolerability as exhibited in adverse effects and laboratory parameters; making a comparison between 2 recommended dosages; and observing the drug’s ability to improve quality of life. Dr. Falk Pharma expects to enroll approximately 760 UC patients in over 120 sites across Europe.