Altheus Therapeutics completes dosing of ZA201 in Phase 2 trial of Zoenasa for ulcerative colitis

Altheus Therapeutics, Inc., announced completion of dosing in ZA201, a double-blind, active-controlled Phase 2 trial evaluating the efficacy and safety of Zoenasa® Rectal Gel versus mesalamine enema in 120 patients with left-sided ulcerative colitis.

The primary endpoint of ZA201 is reduction in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. Secondary endpoints include endoscopic remission, reduction in UCDAI at 3 weeks, and time to resolution of rectal bleeding; there are additional exploratory endpoints. Topline results will be available in April 2014.

"The ZA201 study design sets a high hurdle for Zoenasa; superiority over mesalamine standard of care. Positive results will validate the entire Zoenasa platform, so we are pleased to have achieved this critical milestone," commented Dr. Richard Harty, Founder and CSO of Altheus. "Pending positive results from ZA201, we look forward to continuing development of Zoenasa Rectal Gel and accelerating development of Zoenasa Oral Tablets."

Nearly 1.2 million Americans suffer from inflammatory bowel disease. First-line treatment for ulcerative colitis is mesalamine; however, many patients do not achieve symptomatic or endoscopic remission and must escalate to more expensive treatments that also entail greater risks.

Zoenasa is a novel combination of two FDA-approved drugs, with well-established efficacy and safety records. The combination therapy's intellectual property protection includes patents based on an unexpected synergy shown to improve the signs and symptoms of ulcerative colitis. The U.S. Food and Drug Administration has granted Zoenasa orphan drug designation for the treatment of pediatric ulcerative colitis. An oral formulation of Zoenasa is also in development.