There is a pioneering quality to Oklahoma City-based Altheus Therapeutics and the milestones the company has achieved in advancing a new drug therapy for a painful condition known as inflammatory bowel disease.
In June 2012, Altheus became the first Oklahoma-based company to launch a Phase 2 trial of a medical drug developed in the Sooner State.
The Altheus formulation was conceived by Dr. Richard Harty, a scientist who studied inflammatory bowel disease for more than three decades, including 14 years as chief of gastroenterology and digestive disease at the University of Oklahoma Health Sciences Center.
Dr. Harty proposed to combine an aspirin derivative called mesalamine with an antioxidant called N-acetylcysteine as a drug therapy for inflammatory bowel disease, which includes ulcerative colitis and Crohn's disease.
“I knew that mesalamine was the standard of care for ulcerative colitis and thought if we added an anti-inflammatory, antioxidant, that might make the two work together better,” Dr. Harty said. “We tested it on rodent models of colitis and the combo was shown to be better than either agent alone in reducing inflammation and promoting mucosal healing.”
After the animal studies demonstrated that the formulation lessened the severity of colon inflammation, Dr. Harty licensed the technology from OU and founded Altheus in 2007. Today he is the company's chief scientific officer.
The Phase 2 study of 120 patients at 45 medical clinics across the country involves the Altheus formulation known as Zoenasa. The Food and Drug Administration requires new drugs under development to undergo three phases of clinical studies that prove both their safety and their efficacy.
Results should be known as early as March, said Justin Briggs, the company's director of corporate development and operations.
Dr. Harty and Briggs recently welcomed a visitor to a conference room at the OU University Research Park offices of Altheus, where they pondered the question of why the company was the first in Oklahoma to take a drug into a Phase 2 trial. Another Oklahoma City-based company, Selexys Pharmaceuticals, has since begun a Phase 2 study in the development of its drug to treat sickle cell disease.
The Altheus executives cited several factors, including the fact that Oklahoma has only a decade or so of commercial drug development experience.
“It's incredibly difficult to develop a drug,” Briggs said. “Many fail, get relocated, or stall.”
In addition, investment capital is more available today for life science startups such as Altheus to develop their drugs in Oklahoma rather than sell out quickly to investors who want to relocate the company elsewhere.
“I think a lot depends on the support we've received from the state, from state investors, from regional investors and the Presbyterian Health Foundation,” Dr. Harty said. “Just having a place to hang our hat has been very helpful.”
Altheus has survived the long pre-revenue drug development period by raising $12.5 million in investment capital and another $2.5 million in federal and state research grants. Lead investors were ProLog Ventures from St. Louis, the Oklahoma Life Science Fund, the Chickasaw Nation, Oklahoma Equity Partners and i2E.
“We've been able to stay here and raise the money we need to get to clinical studies, and that shows the maturation of the market,” Briggs said. “It is an important milestone to have not one but two active Phase 2 clinical trials going on in Oklahoma-based companies whose operations are still here.”
He looked across the table at the company's founder.
“Dr. Harty is definitely an Oklahoma pioneer,” Briggs said.
Jim Stafford is communications specialist with i2E Inc. in Oklahoma City.