NATURE Study to Compare LT-NS001 vs. naproxen in Phase 2b Clinical Study
WALTHAM, Mass., April 26 /PRNewswire-USNewswire/ -- 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).
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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®.
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"Following the success of our proof-of-concept study of LT-NS001 vs. naproxen, the opportunity to demonstrate that our Bio-activated(TM) 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.
About the NATURE Study
The NATURE (Naproxen etemesil for Arthritis Treatment and Ulcer Reduction Evaluation) study design is a double-blind, double-dummy, twelve-week study of LT-NS001 (naproxen etemesil) vs. Naprosyn® (naproxen) in patients aged 45 to 80 years with osteoarthritis of the knee requiring ongoing NSAID therapy. The study is expected to complete enrollment in the fourth quarter of 2010 with 534 patients in the United States and United Kingdom. Patients will be randomly assigned to either LT-NS001 or Naprosyn® and will undergo endoscopies at months one, two and three. The primary endpoint is the cumulative incidence of subjects with gastric ulcers in each arm.
In addition to GI safety, injury and tolerability, the study will assess the efficacy of LT-NS001, through the use of the WOMAC functional score, stiffness score and total score for the index knee joint. This evaluation of osteoarthritis pain is designed to confirm the efficacy of LT-NS001, as compared to a therapeutically equivalent dose of naproxen during 12 weeks of B ID dosing, and may be particularly useful for prescribing physicians who are familiar with the use of naproxen.
About LT-NS001
LT-NS001 is the first in a new class of Bio-activated(TM) Prodrugs being developed for the treatment of chronic inflammatory conditions, such as osteoarthritis and rheumatoid arthritis. Prodrugs are compounds that are inactive until enzymes in the body activate them. Logical's NSAID prodrugs are unique because they are activated only when they reach the bloodstream. Because they are not active in the gastrointestinal tract, they avoid GI injury and provide improved overall GI safety.
Despite the wide availability of gastro-protective agents such as proton pump inhibitors (PPI) or histamine-2 receptor antagonists (H2), serious NSAID-induced GI complications, including hemorrhage and perforation persist and are directly responsible for approximately 20,000 deaths in the U.S. each year. Furthermore, the chronic administration of PPIs 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 proprietary technology which has demonstrated improved GI safety without the need for concomitant alkalinizing agents and their associated risks.
NSAIDs are among the most commonly used medications in the world. Older age and the need for regular NSAID therapy increase the risk of NSAID-induced GI complications. The use of NSAIDs is also associated with serious cardiovascular risks, including an increased risk of heart attacks and strokes. LT-NS001 is converted by enzymes to naproxen, which is widely regarded as the NSAID with the most favorable cardiovascular safety profile among all of the drugs in this class.
LT-NS001 is an investigational drug product candidate undergoing clinical evaluation and has not been approved by the U.S. Food and Drug Administration.
About Logical Therapeutics, Inc.
Based in Waltham, MA, Logical Therapeutics, Inc. is a venture-backed, privately held biotechnology company focused on the development of Bio-activated Prodrugs to treat inflammatory conditions such as osteoarthritis and rheumatoid arthritis. The Company's Bio-activated Technology(TM) has created a portfolio of molecules including LT-NS001, a naproxen prodrug and several additional Bio-activated NSAID pro-drug candidates, covered by issued and pending patents throughout the world. Each program addresses unmet medical needs in multi-billion dollar markets. For more information about Logical Therapeutics, visit the Company's website at www.logicaltx.com.
Please address inquiries regarding LT-NS001 to Logical Therapeutics' business development department at [email protected].
Bio-activated Technology(TM) is a trademark of Logical Therapeutics, Inc.
SOURCE Logical Therapeutics, Inc.
