LT-02

Drug Overview

LT-02 (Lipid Therapeutics/Dr Falk) is a modified-release formulation of phosphatidylcholine that is in Phase III development for the treatment of ulcerative colitis. The therapy is designed to improve the function of the intestinal mucosal barrier, which is impaired in ulcerative colitis patients. Phosphatidylcholine is an essential component of the intestinal mucosal barrier, and patients with ulcerative colitis have low intrinsic mucus phosphatidylcholine content, which results in the diminished function of the hydrophobic barrier in the intestinal mucus. This enables colonic bacteria to permeate the barrier, causing an immune response that leads to inflammation and ulceration.

Analyst Outlook

Dr Falk and Lipid Therapeutics are seeking to position LT-02 (phosphatidylcholine; Lipid Therapeutics/Dr Falk) as both a first-line therapy for maintaining remission of mildly to moderately active ulcerative colitis and as a second-line therapy for inducing remission of mildly to moderately active ulcerative colitis. This treatment flexibility will enable LT-02 to target high patient numbers, which means greater sales potential. However, it will be forced to compete with many long-established and often cheaper therapies. Datamonitor Healthcare believes LT-02 would be in a better position to compete with branded and generic corticosteroids if a direct comparison were made in a clinical trial, with the hope that demonstrating enhanced safety of LT-02 compared to corticosteroids might convince some payers and gastroenterologists to choose the new therapy, even if it is more expensive.