FDA Clears First Tranzyme Compound for Clinical Trial

Tranzyme disclosed Tuesday that the Food and Drug Administration had approved an investigational new drug application for one of its compounds. The decision clears the way for the launching of a Phase I clinical trial in February.

"This is the first drug to go to clinical trial for the company, and we are extremely excited about that," said Gordana Kosutic, vice president for clinical and regulatory affairs. "It is a very significant milestone for our company."

Tranzyme is focused on drugs for the treatment of gastrointestinal and metabolic disorders.

The first compound approved for trial with humans is known as TZP-101. It is intended to treat post-operative ileus and other gastrointestinal motility, or movement, disorders. Ileus means that passage through the gastrointestinal tract is not possible or is difficult.

"Post operatively, patients cannot eat and do not have bowel movements," Kosutic explained. "There are approximately 2 million cases a year in the United States with some form of post-operative motility (disorders). What we are trying to achieve is motility - to allow the proper food intake and proper bowel movement."

These gastrointestinal problems are cited as a reason for prolonged post-operative stays in hospitals, she added, noting also that therapeutic options are limited.

TZP-101 was developed internally at Tranzyme over a period of several years, Kosutic said.

The compound is based in part on a peptide hormone called ghrelin. According to Tranzyme, data from animals suggests that ghrelin "accelerates gastric emptying, enhances small bowel transit, and reverses delayed GI transit stemming from surgery or opioid therapy."

Tranzyme closed on $32 million in an oversubscribed B round in May of last year.