Logical Therapeutics Announces Positive Results of LT-NS001 vs. Naproxen Clinical Study

Logical Therapeutics Announces Positive Results of LT-NS001 vs. Naproxen
Clinical Study

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

SAN DIEGO, Oct. 27 /PRNewswire/ -- 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."

Key Findings Presented at ACG
In this study, 120 normal volunteers aged 45 to 70 years received either
LT-NS001 (n=61) or Naprosyn(®) (naproxen) (n=59) for seven days and underwent
an upper GI endoscopy at baseline and on day seven to visualize the extent of
GI injury. At the conclusion of the study, nine subjects (15.8%) had
developed gastric ulcers while taking naproxen, compared with only two
subjects (3.3%) on LT-NS001, a 78 percent reduction in the incidence of
gastric ulcers (p=0.02). The total number of ulcers that developed in the
naproxen arm was twenty-nine (29) compared to only three (3) in the LT-NS001
arm, leading to a significant difference in the mean number of gastric ulcers
per subject (p=0.03). Additionally, subjects receiving LT-NS001 developed no
duodenal ulcers. The primary endpoint for the trial, total modified
gastroduodenal Lanza score (an indicator of GI injury) demonstrated less
overall GI mucosal injury in the LT-NS001 subjects as compared to subjects
receiving naproxen (p=0.03). Treatment emergent adverse events also favored
LT-NS001 with no serious or severe adverse events, including fewer incidences
of abdominal pain, gastritis and dyspepsia.

"The results of this initial study demonstrate a potential new approach to the
treatment of patients who suffer from chronic painful diseases such as
osteoarthritis with the use of an NSAID having the possibility of a lower
incidence of GI side effects traditionally associated with naproxen," said
Thomas J. Schnitzer, MD, PhD, Professor of Medicine, Internal
Medicine/Rheumatology at Northwestern University Feinberg School of Medicine.
"LT-NS001 has the potential to be a very valuable option for patients and
health care providers if further studies with LT-NS001 demonstrate a reduced
risk for NSAID-induced GI complications, a side effect which often results in
discontinuation of arthritis 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 proprietary technology which has demonstrated improved GI safety
without the need for concomitant alkalinizing agents and their associated
risks.

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 products
that treat diseases associated with inflammation. The company is developing a
novel platform of bio-activated prodrugs, covered by an intellectual property
portfolio. LT-NS001, a naproxen bio-activated prodrug, is the Company's lead
compound, with additional NSAID prodrug candidates in development. Each
program addresses unmet medical needs in multi-billion dollar markets. For
more information on Logical Therapeutics, visit the company's website at
www.logicaltx.com.

Please address inquiries regarding LT-NS001 to Logical Therapeutics' business
development department at bd@logicaltx.com.

SOURCE Logical Therapeutics, Inc.

Shanna Duncan or Susan Haralson, both for Logical Therapeutics, Inc.,
+1-202-872-4860