Altheus Therapeutics of Oklahoma City, Okla., has completed a two dose, double-blind, active-controlled phase I trial of the safety and tolerability of Zoenasa rectal suspension in adult patients with left-sided, or distal, ulcerative colitis.
"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," said Dennis Schafer, president and CEO of Altheus.
Front-line treatment for ulcerative colitis, which affects nearly 1.2 million Americans, 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. No serious adverse events were experienced by patients in this study.
The FDA has granted Zoenasa orphan designation for the treatment of pediatric ulcerative colitis. An oral formulation of Zoenasa is in pre-clinical development.