Logical Therapeutics Inc. Announces Results Of Phase 1b Clinical Study Of Its Naproxen Prodrug

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Aug 2008 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Logical Therapeutics, Inc., a biotechnology company focused on the development of medicines that treat diseases associated with poorly controlled inflammation, announced the successful completion of its Phase 1b randomized controlled multi-dose safety and pharmacokinetics study of LT-NS001, the Company's proprietary naproxen prodrug. The study, which was conducted from December, 2007 through July, 2008 in normal adult volunteers, showed that LT-NS001 was well-tolerated by the recipients. Moreover, when the subjects in the study were dosed twice daily with LT-NS001 for seven days, plasma concentrations of naproxen were within the therapeutic range.

LT-NS001 is a prodrug, which is converted in the bloodstream into naproxen, a non-steroidal anti-inflammatory drug (NSAID). Naproxen is widely regarded as the NSAID with the most favorable cardiovascular safety profile among all of the drugs in this class. In pre-clinical studies in rats and dogs, LT-NS001 was shown to cause significantly less damage to the gastrointestinal tract than equivalent doses of naproxen. LT-NS001 has completed pre-clinical toxicology testing and was previously evaluated in a Phase 1a randomized controlled single-dose and multiple-dose study and shown to be well tolerated.

"The robust pre-clinical data package for LT-NS001 suggests that this novel compound will provide patients with a drug that combines the efficacy and cardiovascular safety of naproxen while substantially decreasing the risk for gastrointestinal ulceration," said Dr. Mitchell Fink, the President and CEO of Logical Therapeutics, Inc. "The results from our recently completed P1b study of LT-NS001 are very encouraging, because they show that administration of the pro-drug leads to clinically useful circulating levels of naproxen."

Physicians and patients have accumulated more than 30 years of experience with naproxen, which is widely prescribed to treat pain and other signs and symptoms of inflammation caused by chronic conditions, such as osteoarthritis and rheumatoid arthritis. Despite its considerable efficacy and its good cardiovascular safety profile, naproxen, like most NSAIDs, can cause serious, even life-threatening, gastrointestinal complications. A safer alternative would fulfill a significant unmet medical need.

The company expects to begin enrolling subjects in its next clinical study of LT-NS001 later this year.

About Logical Therapeutics Inc.

Logical Therapeutics, Inc. is a privately held biotechnology company based in Waltham, Massachusetts. Logical Therapeutics is developing drugs to treat a variety of medical conditions that are associated with excessive inflammation, including osteoarthritis and rheumatoid arthritis.

Logical Therapeutics, Inc.
http://www.logicaltherapeutics.com