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Logical Therapeutics Announces Positive Results of LT-NS001 vs. Naproxen Clinical Study
Date:10/27/2009

s therapy."

In the current study, LT-NS001 demonstrated comparable serum concentrations of naproxen at steady state, as measured by AUC and Cmax. Despite this equivalent systemic exposure to naproxen, a significant differential effect on mucosal injury rates was observed for the prodrug LT-NS001, which is pharmacologically inactive as a COX inhibitor until metabolized, as compared to naproxen.

About LT-NS001

LT-NS001 is the first in a new class of bio-activated prodrugs being developed for the chronic treatment of arthritic conditions. It is a novel, patented new chemical entity (NCE) prodrug of the non-steroidal anti-inflammatory drug (NSAID) naproxen, which has been engineered by Logical Therapeutics to significantly reduce the GI safety risks, including the formation of ulcers, associated with naproxen. LT-NS001 is unique among NSAIDs as it is pharmacologically inactive as a COX inhibitor in the GI tract, but once absorbed into the bloodstream, it is converted rapidly and quantitatively to naproxen. Naproxen is widely regarded as the NSAID with the most favorable cardiovascular safety profile among all of the drugs in this class.

Despite the availability of gastro-protective agents, serious NSAID-induced GI complications, such as hemorrhage and perforation, persist and are directly responsible for approximately 20,000 deaths in the U.S. each year. Older age and the need for regular NSAID therapy increase the risk of NSAID-induced GI complications.

Unlike other drugs currently in development which utilize a generic combination of an NSAID with a proton pump inhibitor (PPI) or a histamine-2 receptor antagonist (H2), LT-NS001 is a single agent, non-substitutable NSAID. The chronic administration of PPI's has been associated with serious side effects such as interference with anti-platelet treatments, increased susceptibility to infections and increased risk of bone fracture. LT-NS001 utilizes a prop
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SOURCE Logical Therapeutics, Inc.
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