Washington Editor

The story behind the 2006 founding of Oklahoma City-based Altheus Therapeutics Inc. is a typical tech transfer tale of identifying a technology and turning it into a business model, said CEO Adam Payne.

"We had identified a series of technologies that were being developed at the University of Oklahoma, and we determined that the application of those technologies for the treatment of various conditions within inflammatory bowel disease (IBD) would have strong potential clinical utility for gastroenterologists in meeting the mild-to-moderate symptoms of active ulcerative colitis and Crohn's disease," he said.

The firm's chief scientific officer and discoverer of Altheus' technology, Richard Harty, had been with the university for 30 years, 15 as the chief of gastroenterology.

Altheus is focusing on a novel combination approach of using two compounds instead of the one typically used to treat IBD, which Payne noted is very different from irritable bowel syndrome.

IBD refers to the two chronic diseases that cause inflammation of the intestines: ulcerative colitis and Crohn's disease.

Ulcerative colitis is an inflammation of the large intestine, or colon, and often leads to severe and frequent diarrhea, with mucus and blood often appearing in the stool.

Crohn's disease mostly affects the part of the small intestine known as the ileum, but it also can affect other parts of the digestive system, including the large intestine.

Crohn's disease generally attacks the entire bowel wall, whereas ulcerative colitis attacks only the bowel lining.

IBD affects about 1.2 million people in the U.S. and about 1.3 million people in Europe.

Altheus' IBD treatment approach involves combining 5-aminosalicylic acid (5ASA), a compound widely used as a first-line therapy for IBD, with a second undisclosed FDA-approved compound, Payne said.

5ASA has about a $1 billion market in the U.S. and about $2 billion globally, he noted. However, not all patients respond to the single drug.

Altheus' approach of combing the two compounds, Payne said, "synergizes the activity of the therapy, and we've seen essentially a dramatic increase in efficacy of 5ASA" in preclinical models.

5ASA is typically delivered intraluminally in suppository or rectal enema formulations, Payne said. Altheus is developing both oral and rectal formulations of its combination compound, he noted.

The company expects to be in clinical trials with the rectal formulation by the third quarter of 2008 and the first quarter of 2009 for the oral therapy, Payne said.

Altheus secured $3.6 million in first-round venture capital financing in September. (See BioWorld Today, Sept. 7, 2007.) The firm plans to extend the round to other investors for a total of about $8 million, Payne said, adding that the company plans to close that round within the next three months.

The funds primarily will be used for investigational new drug application activities and materials, he noted.

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