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news.The FDA has given Tranzyme Pharma the all-clear to begin clinical testing of its investigational drug TZP-101 for the treatment of post-operative ileus and other gastrointestinal motility disorders.
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TZP-101 is targeted at ghrelin, a peptide hormone secreted by the stomach and small intestine which plays a physiological role in the stimulation of gastrointestinal (GI) motility.
Animal data suggest that ghrelin accelerates gastric emptying, enhances small bowel transit, and reverses delayed GI transit stemming from surgery or opioid therapy.
The phase I trial will be a placebo-controlled dose escalation study designed to evaluate safety, tolerability, and pharmacodynamic parameters of TZP-101.
“The initiation of phase I studies is a significant step in the development of a mechanism-based therapeutic for the management of delayed gastric emptying,” said Dr Gordana Kosutic, vice president of clinical and regulatory affairs for Tranzyme Pharma. “Disorders of delayed gastric emptying, such as post-operative ileus and gastroparesis, currently have limited therapeutic options.”