Positive results from Logical Therapeutics' Phase I/II LT-NS001 clinical study

Oct 27 2009

Bio-activated Prodrug Demonstrates Significant Reduction in Incidence of GI Ulcers and Erosions

Logical Therapeutics, Inc., a Waltham, MA-based biopharmaceutical company announced today the positive results of a Phase I/II clinical trial evaluating the gastrointestinal (GI) safety of its investigational drug LT-NS001, the first of a new class of bio-activated prodrugs being developed for the chronic treatment of arthritic conditions. In the study, subjects receiving LT-NS001 experienced a 78 percent reduction in the rate of gastric ulcers, and fewer gastric and duodenal erosions, when compared with subjects receiving Naprosyn(®) (naproxen). The LT-NS001 prodrug is unique among non-steroidal anti-inflammatory drugs (NSAIDs) as it is pharmacologically inactive as a COX inhibitor in the GI tract, but once absorbed into the bloodstream, it is converted rapidly to naproxen. LT-NS001 has been engineered to reduce the GI safety risks associated with NSAIDs. Results were announced here at the American College of Gastroenterology's (ACG) Annual Scientific Meeting and presented by Jay L. Goldstein, MD, FACG, Professor of Medicine at the University of Illinois at Chicago, who was the lead investigator for the study.

"The positive results of this study challenge the conventional wisdom regarding NSAID-induced gastrointestinal injury, which physicians generally believe can be driven by systemic exposure to the drug. This study demonstrates that a novel mechanism for NSAID therapy, namely a bio-activated prodrug technology, can provide a significant level of improvement in GI safety, and that may be surprising to many physicians," said Peter A. Lankau, Chief Executive Officer of Logical Therapeutics. "This study brings us one step closer to fulfilling a significant unmet medical need for an NSAID with an improved GI toxicity profile and we look forward to continuing the clinical development of LT-NS001 with our next study scheduled to begin later this year."