ZA-201 A Phase II Double-Blind, Randomized, Comparator-Controlled Study of the Safety and Efficacy of Zoenasa Rectal Gel in subjects with Left-Sided Ulcerative Colitis

Confidential Human Clinical Trial Phase 2 Official Title: A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis Purpose This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion. Further study details as provided by Altheus Therapeutics, Inc.: Primary Outcome Measures: •Change in modified UCDAI at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine Secondary Outcome Measures: •Change in modified UCDAI at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine •Clinical and endoscopic remission rates at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline •Clinical and endoscopic remission rates at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline •Clinical improvement rate after 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] •Clinical improvement rate after 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] •Endoscopic improvement rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] •Endoscopic improvement rate at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] •Change from baseline in endoscopic appearance after 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] •Change from baseline in endoscopic appearance after 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] •Time to resolution of rectal bleeding [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ] •Relapse rates at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] Estimated Enrollment: 120 Study Start Date: June 2012 Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)