Staff Writer

It's full speed ahead for privately held Tranzyme Pharma, which pulled in an additional $20 million in venture financing to support ongoing clinical development of its lead drug candidate, a ghrelin receptor agonist, in severe gastroparesis and postoperative ileus.

The company, which last pulled in $32 million in May 2005, has raised $56 million to date. The latest round, led by Atlanta-based H.I.G. Ventures, Stamford; Conn.-based Thomas, McNerney & Partners; Philadelphia-based Quaker BioVentures; and Montreal-based BDC Venture Capital, should "provide us about 12 months of funding," said Vipin Garg, president and CEO, but more importantly, should see the company through the completion of Phase IIb studies of TZP-101 in two gastrointestinal indications. (See BioWorld Today, May 13, 2005.)

"Obviously, we'll be spending a lot of money over the next year to reach those critical milestones," he told BioWorld Today.

Tranzyme initiated a Phase IIb study in July to test TZP-101 in postoperative ileus (POI), and earlier this week, began a second Phase IIb study in severe gastroparesis. Both are large trials - the POI study is expected to enroll between 200 and 250 patients, and the gastroparesis study will involve about 100 patients - and should enable the company to "get a clear yes or no answer" as to the drug's efficacy, Garg said. Results from both studies, expected in the first half of 2008, will "turn a very important card for us."

While a handful of other firms, such as Cambridge, Mass.-based Elixir Pharmaceuticals Inc., are developing ghrelin agonists for indications such as obesity and cancer cachexia, Tranzyme is focusing strictly on gastrointestinal motility. "What we're doing is targeting the GI tract to modulate or increase GI motility," Garg said. Tranzyme initially is developing the drug as an intravenous formulation, though it's working on a follow-on product for oral administration that could be used in chronic GI motility indications, such as mild to moderate gastroparesis and gastroesophageal reflux disease.

In preclinical studies TZP-101 demonstrated positive results in POI, showing that the drug demonstrated the ability to quickly restore function impaired by surgery, opioid treatment and high-calorie meals. It also showed promise in gastroparesis, or delayed gastric emptying, an indication for which it has gained fast-track status in the U.S., owing namely to the lack of available therapies. The need for treatment increased following the removal of cisipride, sold as Propulsid by Johnson & Johnson, from the market in 2000 due to cardiovascular side effects.

At the time cisipride was yanked from shelves, it had been reporting close to $1 billion in sales, Garg said, "and that patient population has only grown since then because of the prevalence of diabetes," the most common cause of gastroparesis.

Since TZP-101 clearly has blockbuster potential, Tranzyme likely will consider partnerships once it has Phase IIb data in hand. "We've already had a lot of interest," Garg said, though it's possible the company will opt to build its own small sales force to hit the acute care market. Tranzyme's advantage is in having "multiple shots on goal with each drug and multiple market segments," he added. "It's really critical in today's market to have that kind of flexibility."

Beyond TZP-101, the company has TZP-201, a motilin antagonist, for moderate to severe diarrhea and TZP-301 for obesity and metabolic syndrome. All Tranzyme's candidates were created in house, using its core chemistry technology. Though "we've got enough on our plate right now, our platform could be deployed for additional" programs, Garg said. The company, however, is open to "executing some strong partnerships" with firms that have strong biology platforms and are in need of complementary chemistry services.

Tranzyme, which has offices in Research Triangle Park, N.C., and Sherbrooke, Quebec, employs 44 people, the majority of them working in the area of research and development.