-- Trial Marks the Second Compound to Enter Proof-of-Concept Studies within
the Last Month --
WALTHAM, Mass., Oct. 17 /PRNewswire/ -- Dynogen Pharmaceuticals, Inc.
announced today that it has initiated a Phase II proof-of-concept trial of
DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d), and the
first patients have been dosed. DDP225 is an orally-active compound that
targets two key pathways that control the gastrointestinal (GI) system, thus
giving it the potential to address multiple symptoms associated with IBS-d.
This DDP225 Phase II trial is a randomized, double-blind, placebo controlled
study that is enrolling patients with IBS-d at multiple centers in Canada and
is assessing safety and pharmacodynamic efficacy as well as symptom-based
endpoints. In September 2005, Dynogen began dosing patients in a Phase II
study of DDP733 for the treatment of patients with constipation-predominant
IBS (IBS-c), the other common form of IBS.
"The achievement of this important milestone for Dynogen highlights the
successful implementation of our in-licensing strategy. In less than two
years since acquiring rights to this compound, we have conducted extensive in
vivo preclinical research and initiated this Phase II proof-of-concept trial,"
said Lee R. Brettman, M.D., Chief Executive Officer at Dynogen. "Dynogen now
has two promising and complementary drugs in Phase II proof-of-concept trials
that address the two major types of IBS: DDP225 for patients with diarrhea-
predominant IBS and DDP733 for patients with constipation-predominant IBS. We
plan to continue this momentum with the initiation of additional human
clinical trials before the end of the year."
"DDP225 is a unique and very promising compound because of its dual
mechanism of action," said Dr. Suhail Nurbhai, MRCP, Vice President of
Clinical Development at Dynogen. "It possesses both noradrenaline reuptake
inhibition and 5-HT3 receptor antagonist properties. We are particularly
excited about the potential for DDP225 for the treatment of IBS-d because this
two-pronged attack may yield significant advantages in addressing the multi-
symptomatic nature of a disorder that has proven difficult to treat."
About DDP225
DDP225 is both a noradrenaline reuptake inhibitor and a serotonin type 3
receptor (5-HT3) antagonist. Noradrenaline and serotonin are
neurotransmitters that are known to be involved in the control of the
gastrointestinal system. The unique combination of noradrenaline reuptake
inhibition and 5-HT3 antagonism in one orally delivered compound represents a
novel approach to treating IBS-d and other functional GI diseases. Dynogen
licensed preclinical and clinical data related to DDP225 from Mitsubishi
Pharma in October 2003.
About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome is a chronic condition that is believed to be
caused by the abnormal function (dysfunction) of the muscles and/or nerves of
the organs of the GI tract. Patients with IBS experience abdominal pain,
discomfort and bloating accompanied by altered bowel habit that can include
either diarrhea, constipation or both. IBS has prevalence of up to 12% of the
general population and females under the age of 45 account for 80% of the
patient population with severe cases. It is the most common disease diagnosed
by gastroenterologists and one of the most common disorders seen by primary
care physicians.
About Dynogen Pharmaceuticals, Inc.
Dynogen is a privately held, neuroscience-based pharmaceutical company
developing more effective treatments for genitourinary and gastrointestinal
disorders. Today, Dynogen has three clinical development candidates, DDP200
for overactive bladder, DDP225 for diarrhea-predominant irritable bowel
syndrome (IBS-d) and chronic functional vomiting (CFV), and DDP733 for
constipation-predominant IBS (IBS-c) and nocturnal gastroesophageal reflux
disease (NGERD). More information about the Company can be found by visiting
our website http://www.dynogen.com.
SOURCE Dynogen Pharmaceuticals, Inc.
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Related links:
http://www.dynogen.com
CONTACT:
Mark Boshar of Dynogen Pharmaceuticals, Inc.,
+1-781-839-5114, mboshar@dynogen.com; or Kari Watson of
MacDougall Biomedical Communications, +1-508-647-0209, ext. 11,
kwatson@macbiocom.com
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