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Tranzyme Pharma Initiates Dosing of Patients in a Multi-National Phase
IIb Clinical Trial for the Treatment of Severe Gastroparesis
RESEARCH TRIANGLE PARK, N.C.
and SHERBROOKE, Québec (October 30, 2007) - Tranzyme
Pharma today announced the initiation of a Phase IIb clinical
trial of its potent intravenous ghrelin agonist, TZP-101, for
the management of severe gastroparesis. TZP-101 is a
first-in-class prokinetic agent under development for the
treatment of selected GI motility disorders. In July 2007,
Tranzyme initiated enrollment in a Phase IIb clinical trial for
post-operative ileus.
The severe gastroparesis Phase IIb trial, now underway in the
US, Denmark and Sweden, is a multicenter, randomized,
double-blind, placebo-controlled, dose-ranging study to assess
the efficacy and safety of TZP-101 in subjects suffering from
severe diabetic gastroparesis. The study has an adaptive
randomization design, and could potentially enroll up to 100
subjects. The primary objective of this study is to assess the
impact of TZP-101 on symptoms as defined by a change from
baseline in a validated gastroparesis symptom scoring
assessment.
In July 2007, TZP-101 received fast track designation from the
FDA for the treatment of severe gastroparesis based on
Tranzyme’s positive Phase IIa clinical data. In the Phase IIa
study, TZP-101 not only demonstrated a statistically significant
increase in gastric emptying (measured by scintigraphy) but also
improved symptoms in 10 patients with long-standing diabetes,
poor glycemic control, and significant gastropathy. Postprandial
fullness, the most frequent and severe symptom observed with
these patients, was reduced 37% by TZP-101. This
state-of-the-art simultaneous controlled investigation, carried
out during euglycemic hyperinsulinemic clamp (in highly
selective homogenous patients), demonstrated for the first time
that TZP-101 both accelerates gastric emptying of solid food and
improves symptoms characteristic of gastroparesis. These
observations clearly suggest that TZP-101 is a potential
break-through drug for the management of severe gastroparesis.
Severe gastroparesis is a cause of significant patient
morbidity. Frequent hospitalizations, emergency room and
physician office visits may result from the difficulties in
managing this disorder and its diabetes-associated metabolic
complications. The impact on people’s lives, and the economic
and resource burdens that gastroparesis places on the healthcare
system, stresses the importance of developing an effective and
safe treatment for this indication. Most current drug treatments
are only moderately effective at best, and may cause
neurological side effects.
“As of today, no efficient treatment for diabetic gastroparesis
exists. The ability of TZP-101 to address both gastric emptying
and symptoms of gastroparesis will potentially make this drug a
unique first-in-class treatment for this extremely difficult
medical condition,” said Dr. Niels Ejskjaer, principal
investigator from the Aarhus University Hospital, Denmark.
About TZP-101
TZP-101 is a potent, small molecule ghrelin receptor agonist
that Tranzyme is developing for the treatment of severe
gastroparesis and post-operative ileus. The safety and
pharmacokinetic profile of TZP-101 has been characterized in 50
healthy subjects across multiple dose levels. The prokinetic
properties of the compound have been well established in various
animal models of postoperative ileus and more recently in
diabetic patients with severe gastroparesis. In addition to
TZP-101, Tranzyme is developing an oral ghrelin agonist,
TZP-102, for the treatment of mild-to-moderate gastroparesis and
other chronic GI motility disorders.
About Severe Gastroparesis
Gastroparesis is a paralysis of upper gastrointestinal tract
function characterized by delayed gastric emptying in the
absence of a mechanical cause of obstruction. Disease severity
ranges from mild to moderate to severe. Symptoms include
post-prandial fullness, bloating, nausea, vomiting, and upper
abdominal pain. Severe gastroparesis, or gastroparesis with
gastric failure, is characterized by refractory symptoms that
are not controlled despite medical therapy. Patients suffering
from severe gastroparesis are often unable to maintain
nutrition, or medication via oral delivery. Because of their
unremitting symptoms, they may be dependent on gastric
suctioning and enteral/parenteral nutrition. Gastroparesis is a
major complication of diabetes. The World Health Organization
estimates that 180 million people have diabetes. Approximately
5% of Type 1 and 25% of Type 2 diabetic patients, or 13 million
worldwide, are believed to suffer from gastroparesis. In
addition, there may be a nearly equal number of patients who
suffer from gastroparesis due to other causes.
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