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Tranzyme
Pharma Initiates Dosing of Patients in a Multi-National Phase
IIb Clinical Trial with its Novel Ghrelin Agonist, TZP-101, for
Post-Operative Ileus
RESEARCH TRIANGLE PARK, N.C.
and SHERBROOKE, Québec (July 26, 2007) - Tranzyme Pharma,
a leading biopharmaceutical company developing small molecule
drugs for the treatment of gastrointestinal and metabolic
diseases, today announced the initiation of a Phase IIb clinical
trial of its investigational drug, TZP-101, for the management
of post-operative ileus (POI). TZP-101 is a potent ghrelin
agonist that Tranzyme is developing as a first-in-class
prokinetic agent for the treatment of POI and severe
gastroparesis.
The POI Phase IIb trial, now underway in the USA, Romania and
Lithuania, is a multicenter, randomized, double-blind,
placebo-controlled, dose-ranging study to assess the efficacy
and safety of TZP-101 when administered as a 30 minute i.v.
infusion to subjects undergoing major open abdominal surgery.
The study has an adaptive randomization design, and could
potentially enroll up to 250 patients. The primary objective of
this study is to assess the impact of TZP-101 on postoperative
time to recovery of gastrointestinal (GI) function as defined by
the time to first bowel movement. In addition to efficacy
monitoring, routine clinical, laboratory and ECG monitoring will
be performed to evaluate patient safety.
POI is a cause of significant morbidity in patients subjected to
abdominal and other types of surgery and increases the duration
and cost of hospitalization. The economic and resource burden
that POI places on the healthcare system stresses the importance
of developing an effective and safe treatment for this
indication.
“TZP-101 offers the potential to treat POI through a novel
mechanism of action,” said Vipin K. Garg, Ph.D, President and
CEO of Tranzyme Pharma. “We are pleased to initiate this Phase
II program which results from our internal research efforts and
our proprietary chemistry-based drug discovery platform.”
“It is exciting for Tranzyme that the TZP-101 program has now
entered the more advanced phase of the clinical development
process,” said Gordana Kosutic, M.D., VP of Clinical and
Regulatory Affairs for Tranzyme Pharma. “Tranzyme’s pre-clinical
data have clearly shown that TZP-101 restores motility of the
gastrointestinal tract whether caused by surgical manipulations
of the GI tract or aggravated by the use of drugs such as
opioids. The ability of TZP-101 to treat several underlying
causes of post-operative ileus will potentially make this drug a
unique first-in-class treatment for this medical condition.”
About TZP-101
TZP-101 is a potent, small molecule ghrelin receptor agonist
that Tranzyme is developing as an intravenous drug for the
treatment of post-operative ileus and severe gastroparesis. 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 chronic GI motility
disorders.
About Post-Operative Ileus
Post-operative ileus is a transient impairment of GI motility
following abdominal or other surgery. Common symptoms include
abdominal distention or bloating, pain, nausea and vomiting, and
inability to pass stools and tolerate a solid diet. A delay in
resuming a normal diet may lead to poor healing through a
cascade of events. A greater risk for pulmonary complications
also exists, since POI may result in reduced patient mobility.
POI is associated with an increased length of hospital stay. It
has been reported that POI is the most common cause of delayed
hospital discharge after abdominal surgery. In the United States
alone, it is estimated that 22 million patients undergo surgical
procedures requiring pain management and of these patients, 2.4
million undergo high risk open surgery each year (Source:
Premier Database). No treatments for POI have been approved by
the US Food and Drug Administration to date.
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