Copyright © 2013 , The Oklahoma Publishing Company
Oklahoma City-based Altheus Therapeutics Inc., said Thursday it has completed enrollment for a six-week, double-blind, active-controlled Phase 2 clinical trial of the efficacy and safety of Zoenasa Rectal Gel in about 120 adult patients with left-sided, or distal, ulcerative colitis.
Top line results are expected to be available in March or early April, the company said.
Altheus CEO Dennis Schafer said, “We look forward to gaining alignment on our registration program with the FDA (Food and Drug Administration) and other health authorities as the next step to making Zoenasa available to IBD (inflammatory bowel disease) patients.”
Nearly 1.2 million Americans suffer from inflammatory bowel disease. Zoenasa is a patented combination of two FDA-approved drugs that have been shown to act together to improve the signs and symptoms of ulcerative colitis.
From Staff Reports