OKLAHOMA CITY, -- Altheus Therapeutics announced today it has randomized its first patient in a comparator-controlled Phase 2 efficacy study of Zoenasa®, a novel combination therapy for ulcerative colitis (UC).
Zoenasa is a fixed-dose combination of mesalamine (current standard of care in UC) plus a second potent anti-inflammatory agent not previously used in this indication. In multiple animal models and one human study the combination has shown to be 50 to 100 percent more effective than standard therapy. The synergistic effect of the Zoenasa combination was discovered by Altheus' scientific founder, Dr. Richard Harty, past Chief of Gastroenterology at the University of Oklahoma Health Sciences Center.
"We believe that Zoenasa will define a new category within the mesalamine-based market that could improve front-line treatment for ulcerative colitis and alter the market significantly," said Dennis Schafer, Altheus CEO.
Nearly 1.2 million Americans suffer from inflammatory bowel disease, with 2.3 million people affected worldwide. The two most common forms, ulcerative colitis and Crohn's disease, are chronic lifelong conditions which significantly impact quality of life. Front-line treatment for ulcerative colitis is mesalamine. However, many patients do not achieve remission and must escalate to more expensive and risky treatments.
ZA201 is a double-blind, active-controlled Phase 2 study of the safety and efficacy of Zoenasa Rectal Gel and will be conducted at 25 centers in approximately 120 adult patients with left-sided (distal) ulcerative colitis. The study's Principal Investigator is Dr. Philip B. Miner, Jr., of the Oklahoma Foundation for Digestive Research in Oklahoma City, one of the foremost clinical research investigators for IBD. ZA201's first patient was enrolled at Digestive Health Specialists of the Southeast in Dothan, AL, under Dr. Jeffery Crittenden.
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