Lipid Therapeutics has announced that it has successfully filed its first US IND for its lead product 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.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, commented: “We are very pleased to have cleared this important regulatory milestone that paves the way for late-stage development of LT-02 in the US. The strong safety record of our oral phospholipid active ingredient has allowed us to move forward without the need for further non-clinical toxicology or additional human safety studies.”
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.
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.
This is a significant area of high unmet medical need as approximately 40% of patients receiving the maximum dose of mesalazine, the standard 1st line therapy for ulcerative colitis, continue to experience flares of disease activity and therefore require additional treatment.