Date: 2014-10-29
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Lipid Therapeutics (Germany) Dr. Falk Pharma (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. Loss of barrier function in the colon in patients with ulcerative colitis has been linked to inflammation due to prolonged bacterial contact with the gut mucosa. Clinical efficacy of the approach has been demonstrated in several clinical trials, most recently in a Phase IIb trial where LT-02 acheived the primary study endpoint (reduction of disease activity in patients with mesalazine-refractory ulcerative colitis) with statistical significance.
Disease: mild-moderate ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: USA, Europe
Trial
details: The Phase III trials in the US and Europe will be conducted as part of a synchronized global pivotal plan and are expected to begin in Q4 2013. The combined clinical program will involve over 700 patients in each of two induction studies, with the objective of achieving remission based on the primary endpoint of reducing the patient’s Mayo Score. The two induction trials will be followed by a single global maintenance trial.
In the planned global Phase III program LT-02 will be tested as add-on therapy to mesalazine.
Latest
news: * On October 29, 2014, Lipid Therapeutics announced that its European co-development partner Dr. Falk Pharma has enrolled the first patients into a pivotal Phase III trial with LT-02, a novel barrier function therapy for mild-moderately active ulcerative colitis not responding to standard doses of 5-ASA. Dr. Falk Pharma acquired the European rights to LT-02 in 2012 and is responsible for further development and commercialization of the drug in Europe. Lipid Therapeutics also announced that it has received positive scientific advice from the FDA on a planned pivotal Phase III protocol in the US. Based on this feedback a clinical Phase III trial will be conducted in the US involving over 500 patients with the objective of achieving remission based on a meaningful reduction of the Mayo Disease Activity Score as the primary endpoint. The US Phase III trial and the now started European Phase III trial run by Dr. Falk Pharma are part of a global Phase III development program that aims at providing clinical evidence to support approval of LT-02 in 2019 in both territories. In Europe, the randomized, double-blind, double-dummy, placebo-controlled Phase III trial will evaluate the efficacy and safety of LT-02 as an add-on therapy versus placebo in patients with ulcerative colitis refractory to mesalamine. Secondary endpoints include studying the safety and tolerability of LT-02 in the form of adverse events and laboratory parameters; comparing two different dosing regimens of LT-02; and assessing patients' quality of life. Around 760 patients across 120 centers in Europe are expected to be enrolled into the trial. * On April 10, 2013, Lipid Therapeutics has announced that it has successfully filed its first US IND for LT-02 and is now in a position to proceed with a planned Phase III trial in the US in mild-moderate ulcerative colitis patients. The LT-02 IND was subject to the FDA’s customary 30 day review period. The Phase III trials in the US and Europe will be conducted as part of a synchronized global pivotal plan and are expected to begin in Q4 2013. Lipid Therapeutics intends to conduct the US portion of the program with a partner, in parallel with the trials to be conducted in Europe by Lipid Therapeutics’ European licensee for LT-02, Dr. Falk Pharma GmbH. A Phase IIb trial conducted in Europe met its primary endpoint (reduction of disease activity in patients with mesalazine-refractory ulcerative colitis) with statistical significance, following which Dr. Falk converted its option on the product to a license agreement for the European territories.
