Altheus Therapeutics announces completion of Zoenasa phase I trial for ulcerative colitis

Jan 6 2011

Altheus Therapeutics, Inc., announced that it has completed a two dose, double-blind, active-controlled Phase I clinical trial of the safety and tolerability of Zoenasa™ Rectal Suspension in adult patients with left-sided, or distal, ulcerative colitis.  No serious adverse events were experienced by patients in this study.  "We are excited to have achieved this milestone, as it prepares Altheus to begin our planned Phase II clinical program to definitively evaluate the safety and efficacy of Zoenasa in ulcerative colitis patients," commented Dennis Schafer, President and CEO of Altheus.

Nearly 1.2 million Americans suffer from inflammatory bowel disease. The two most common forms, ulcerative colitis and Crohn's disease, are chronic lifelong conditions which significantly impact the quality of life. Front-line treatment for ulcerative colitis is monotherapy with oral or rectal mesalamine.  However many patients do not achieve remission and must escalate to more expensive and risky treatments.

Zoenasa is a novel combination of two FDA-approved drugs with well established efficacy and safety records that have been shown to act synergistically for the treatment of ulcerative colitis.  In animal models of colitis, Zoenasa resolved inflammation more rapidly and completely than standard mesalamine treatment.  Zoenasa Rectal Suspension is being investigated for the treatment of left-sided ulcerative colitis, which affects approximately 80% of ulcerative colitis patients.  The U.S. Food and Drug Administration has granted Zoenasa orphan designation for the treatment of pediatric ulcerative colitis.  An oral formulation of Zoenasa is in pre-clinical development.