Lipid Therapeutics Successfully Files a US IND for LT-02, a Novel Therapy for Ulcerative Colitis

, Germany, April 10, 2013 /PRNewswire/ —
IND paves the way for the US element of a III development program with LT-02 in conjunction with European licensee , whose pivotal study will start in Q4 2013

Lipid Therapeutics announces today 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 . 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- 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 , 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.

Lipid Therapeutics Successfully Files a US IND for LT-02, a Novel Barrier
(press release)
Lipid Therapeutics announces today 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

and more »

Leave a Reply