Lipid Therapeutics Successfully Files a US IND for LT-02
News Apr 11, 2013
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.
Lonza to Establish Cell- and Gene-Therapy Centers of Excellence to Accelerate GrowthNews
Lonza will establish Centers of Excellence for Cell and Gene Therapy to support and accelerate the growth of this priority area for the company.READ MORE
Catalyst Biosciences Announces Positive Top-Line Data for Potential Hemophilia B TreatmentNews
All individuals with severe hemophilia improved to mild hemophilia activity levels after only six daily doses with a continuous linear increase in Factor IX clotting activity. These results suggest that long-term dosing of SQ CB 2679d has the potential to maintain stable clotting activity in the high-mild hemophilia to normal range.READ MORE
Cannabinoids Are Easier on the Brain Than Booze, Study FindsNews
The research was published in the journal Addiction.READ MORE