Logical Therapeutics, Inc (WALTHAM, Massachusetts), a biotechnology company focused on the development of medicines that treat diseases associated with poorly controlled inflammation such as osteoarthritis (OA) and rheumatoid arthritis (RA), announced the successful completion of its randomized, controlled, multidose safety and pharmacokinetics study of LT-NS001, a naproxen prodrug. The phase Ib study, conducted in 47 normal adult volunteers, showed that the agent was well-tolerated. Twice-daily dosing with LT-NS001 for 7 days resulted in plasma concentrations of naproxen within the therapeutic range. No serious adverse events were reported and no subjects withdrew from the study. The company expects to begin enrolling subjects in its next clinical study of the agent later in 2008.

LT-NS001 is rapidly and quantitatively converted to naproxen in the bloodstream. In preclinical studies using animal models of NSAID-induced gastric and/or intestinal mucosal damage, the agent caused significantly fewer ulcers or erosions than did equivalent doses of naproxen. LT-NS001 was as effective as naproxen in rodent models of anti-inflammatory or analgesic efficacy.

Naproxen is widely regarded as the NSAID with the most favorable cardiovascular safety profile among all drugs in this class, however, the company believes that their novel agent will provide patients with a drug that combines the efficacy and cardiovascular safety of naproxen while substantially decreasing the risk for gastrointestinal ulceration.

Licensed from Medinox, Inc in 2006, Logical Therapeutics intends to develop LT-NS001 for the treatment of mild-to-moderate inflammatory conditions, such as OA and low back pain syndrome.

In 2007, Logical Therapeutics raised $30 million in a Series B financing to advance its drug pipeline targeting inflammatory diseases. The company is also working to develop potent TNF-blocking anti-inflammatory agents for the treatment of RA and other chronic inflammatory conditions, which obviate the need for parenteral injections.