Phase 2b clinical study initiated to evaluate GI safety of LT-NS001

Apr 27 2010

NATURE Study to Compare LT-NS001 vs. naproxen in Phase 2b Clinical Study

Logical Therapeutics, Inc., a Waltham, Mass.-based biotechnology company announced today the initiation of a Phase 2b clinical study to evaluate the gastrointestinal (GI) safety of its investigational drug LT-NS001 (naproxen etemesil).  The study will compare the cumulative rate of gastric ulcers vs. Naprosyn® after 12 weeks of treatment.  LT-NS001 is the most advanced compound in Logical's portfolio of patented Bio-activated^TM Prodrugs, which are being developed to improve the GI safety and tolerability of non-steroidal anti-inflammatory drugs (NSAIDs).  

LT-NS001 is pharmacologically inactive as an NSAID in the GI tract, but once absorbed into the bloodstream, it is converted rapidly and completely to the well known NSAID, naproxen. Previously, LT-NS001 demonstrated a significant (79%) decrease in the incidence of gastric ulcers in subjects after just 7.5 days, as compared to Naprosyn®.  

"Following the success of our proof-of-concept study of LT-NS001 vs. naproxen, the opportunity to demonstrate that our Bio-activated™ prodrug may provide a considerable GI safety improvement over traditional naproxen in patients using NSAIDs chronically is quite compelling," said Peter A. Lankau, Chief Executive Officer of Logical Therapeutics.  "We believe the NATURE study will confirm the improved GI safety profile of LT-NS001 and will be predictive of the pivotal endpoints as defined by the FDA. It will bring us one step closer to fulfilling the unmet medical need for a single-entity NSAID with a significantly improved GI safety profile," said Lankau.