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Tioga Pharmaceuticals’ Asimadoline
Demonstrates Positive Results in a Phase 2b Clinical Trial for the
Treatment of Irritable Bowel Syndrome
Statistically Significant Reduction of IBS Pain and Normalizing
Motility Effect Observed
SAN DIEGO, Calif., May 20, 2008 /PRNewswire – Tioga
Pharmaceuticals, Inc. today announced the results of a recent Phase 2b
study of its oral kappa opioid receptor agonist, asimadoline, which
demonstrated statistically significant results in the treatment of
Irritable Bowel Syndrome (IBS). Asimadoline produced significant
improvement in diarrhea-predominant (D-IBS) and alternating (A-IBS)
patients across multiple parameters including the primary endpoint of
pain, as well as secondary endpoints of urgency, frequency and bloating
in both males and females. In D-IBS patients, therapeutic benefit was
observed within the first month of treatment and was sustained for the
three month duration of the trial. Asimadoline appeared to be well
tolerated with no adverse events occurring in a dose-dependent manner
throughout the randomized, double-blind, placebo-controlled,
dose-ranging clinical trial involving 596 subjects. These data were
featured today in a late-breaking oral presentation session at the
Digestive Disease Week 2008 Annual Meeting.
Study Results
Of the 596 patients randomized in the trial, approximately 33
percent were characterized as D-IBS, 37 percent constipation predominant
(C-IBS) and 31 percent alternating between diarrhea and constipation
(A-IBS).
-
In the overall patient group, patients with
at least moderate pain achieved a 17 percent improvement in
percent number of months with adequate relief of IBS pain
compared to placebo (40 percent vs. 23 percent) with both
the 0.5 mg (p=0.006) and the 1.0 mg (p=0.005) dose of
asimadoline.
-
Evaluation by IBS subtype revealed benefit
in D-IBS and A-IBS patients.
-
Benefit in C-IBS patients was not observed.
-
The rate of adverse events was similar in
asimadoline and placebo treated subjects.
-
Patients with D-IBS with at least moderate
pain achieved a 27 percent improvement in the percent number
of months with adequate relief of IBS pain compared to
placebo (47 percent vs. 20 percent, p=0.011) with the 0.5mg
dose of asimadoline.
-
A 25 percent increase in pain free days was
seen with 0.5 mg asimadoline as compared with placebo
(p=0.001) during the 12-week dosing period. This represents
an increase of approximately 20 pain free days over that
seen with placebo.
-
Statistically significant (p<0.05)
improvement in pain was seen by week three and persisted for
the duration of treatment.
-
Statistically significant improvements were
also seen in D-IBS patients receiving the 0.5 mg dose of
asimadoline in all of the following secondary endpoints:
urgency, adequate relief of IBS symptoms, stool frequency,
bloating and daily pain. Statistically significant
improvement was also seen in urgency, adequate relief of IBS
symptoms, bloating and daily pain in patients receiving the
1.0 mg dose.
-
Benefit was seen in female and male
patients.
-
Patients with A-IBS with at least moderate
pain achieved a 23 percent improvement in the percent number
of months with adequate relief of IBS pain compared to
placebo (50 percent vs. 27 percent, p=0.022) with a 1.0 mg
dose of asimadoline.
-
Statistically significant benefit was also
seen in the secondary endpoint of adequate relief of IBS
symptoms in patients receiving the 1.0 mg dose of
asimadoline compared to placebo (57 percent vs. 33 percent,
p=0.032).
-
Benefit was seen in female and male
patients.
Study Design
D-IBS, C-IBS, and A-IBS patients were recruited. Patients underwent a
two-week screening, a 12-week treatment and a four-week follow-up
period, and they received identical appearing placebo, 0.15 mg, 0.5 mg
or 1.0 mg tablets of asimadoline twice daily for the treatment period.
Throughout the trial, patients entered data daily by IVRS (interactive
voice response system). The primary endpoint was number of months a
patient was a responder for adequate relief of pain, where the primary
measure was the question, "In the past 7 days have you had adequate
relief of your IBS pain or discomfort?" asked once every 7 days. A
monthly responder replied "yes" at least three weeks per month. The
secondary endpoints were abdominal pain, stool frequency and
consistency, urgency, bloating, adequate relief of IBS symptoms and
straining. Secondary endpoints were also collected using IVRS. Adverse
events, labs and echocardiograms were also collected.
About Irritable Bowel Syndrome
Irritable bowel syndrome is a common, chronic gastrointestinal disorder
characterized by abdominal pain and discomfort associated with
alterations in bowel habits. The bowel abnormalities may manifest as
diarrhea-predominant disease, constipation-predominant disease, or
alternation between diarrhea and constipation. IBS is estimated to
afflict approximately 12 percent of the adult population in the United
States and Europe, with roughly equal prevalence of each subtype. For
reasons that remain unknown, IBS is a female-predominant disorder, with
two-thirds to three-quarters of the subjects being female.
Lotronex (alosetron), a selective 5-HT3 receptor antagonist, is the only
drug currently approved by the FDA for the treatment of D-IBS; however,
due to safety concerns, Lotronex was removed from the market in 2001 and
re-launched in 2002 under a strict risk management program. No treatment
is currently approved by the FDA for A-IBS. There is, therefore, an
urgent unmet clinical need for a safe and effective treatment for the 20
million Americans who suffer from D-IBS and A-IBS.
About Asimadoline
Asimadoline is an orally administered small molecule that is a highly
selective kappa opioid receptor agonist. Kappa opioid receptors are
found in the digestive tract and are believed to play an important role
in control of visceral pain and bowel motility. Asimadoline was
originally discovered by Merck KGaA of Darmstadt, Germany. In 2005,
Tioga purchased asimadoline from Merck and acquired by assignment all
worldwide rights. Asimadoline has been tested in over 1100 subjects and
has demonstrated a promising safety profile.
About Tioga
Tioga Pharmaceuticals, Inc. is a pharmaceutical company headquartered in
San Diego, CA focused on developing novel treatments for
gastrointestinal diseases. Tioga is currently planning Phase 3
development of asimadoline for the treatment of D-IBS and A-IBS and a
Phase 2b trial of asimadoline for the treatment of functional dyspepsia.
Both disorders represent a large unmet medical need and a substantial
market opportunity. For more information, please visit
www.tiogapharma.com .
Contact: David Urso, Chief Business Officer and General Counsel
Phone: 858-964-5021
Email: urso@tiogapharma.com
Media: Cory Tromblee, Porter Novelli Life Sciences
Phone: 617-897-8294 r> Email: ctromblee@pnlifesciences.com
Source
Tioga Pharmaceuticals, Inc. |