Altheus Therapeutics completes Zoenasa phase I trial in ulcerative colitis

Friday, June 15, 2012 11:34 AM

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.

Share:          
CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs