Tranzyme plans to start phase-I trials of its gastrointestinal drug

North Carolina-based Tranzyme Pharma Inc, a development stage pharmaceutical company, plans to start phase-I clinic trials of its drug focused on disorders of the gastrointestinal (GI) tract by the end of the year.

The company, which has raised $21 million so far, expects to raise between $20 million and $25 million in a fresh round, in the next three months.

Speaking to Business Standard, Vipin K Garg, president and chief executive officer, Tranzyme Pharma, said: "The company is planning five different GI drugs. The first of which would be for post-operative ileus (POI) and we plan to start the clinical trails by the end of the calendar year followed by the trials for a drug for diabetic gastroparesis in 2006."

"The money that we raise would be used for clinical trials and other outsourcing activities," Garg said. According to him, in the US for a company to get recognised it is important to enter the clinical trials quickly and Tranzyme had done it in just over four years.

Apart from developing drugs required for the GI tract such as post-operative ileus and diabetic gastroparesis, the company is also developing drugs for irritable bowel syndrome (diarrhea type) and functional dyspepsia.

Garg said that though many companies had launched similar drugs that were banned in the US because in the long run they would have an impact on the receptors in the brain.

"The molecules we have identified target two validated, druggable G protein-coupled receptors found within the gastrointestinal tract -- ghrelin and motilin. By targeting these two receptors, Tranzyme has identified 'mechanism-based' agents that will not have an affect on the brain," he said

The company is outsourcing the chemistry technologies and research and development to other countries including India. "In India, we operate through the subsidiary of CiVenti Chem LLC, Indus Biosciences located in Hyderabad," he said.

Garg said that initially the company is planning to conduct the phase-I trials in the US and probably for phase-III trials it will look at other countries including India.

"For the first phase of human trials not many patients are required but at an advanced stage we would require many patients and then we would conduct trials in other countries including India," Garg said.

The company is also looking at other biotech companies in the city to outsource its work because of the strengths that are present in the areas of R&D here.

"Moving ahead, the company plans to diversify its drug discovery operations through more than 15 partnerships around the world in the areas such as HIV, small molecule discovery, neurodegenerative diseases, cancer and cystic fibrosis," he said.