US-based speciality biopharmaceutical company Santarus has reported the clinical data from an open-label study designed to investigate the efficacy and safety of eight weeks of treatment with the Uceris (budesonide) 9mg tablets in patients with mild or moderate active ulcerative colitis.
Uceris is a locally acting corticosteroid indicated for induction of remission of active ulcerative colitis.
In collaboration with Cosmo Technologies, Santaris conducted an open-label clinical study with Uceris, as a companion study to a pivotal Phase III clinical study in patients with mild or moderate active ulcerative colitis.
Patients who had failed to achieve clinical and endoscopic remission in an earlier pivotal Phase III eight week induction study were eligible for the open-label study.
The open-label study also evaluated clinical improvement, endoscopic improvement and symptom resolution of the drug candidate at the end of the treatment.
Sixty patients were enrolled in the Uceris 9mg open-label study. The overall rate of remission was 25%, clinical improvement was 26.7%, endoscopic improvement was 40% and symptom resolution was 33.3%.
The primary endpoint included induction of clinical and endoscopic remission, estimated by an Ulcerative Colitis Disease Activity Index score of =1 after eight weeks, with scores of zero for rectal bleeding and stool frequency, no mucosal friability after colonoscopy, and = 1 point reduction from baseline in the endoscopic index score.
Santarus medical affairs and pharmacovigilance senior vice-president David Ballard said the open-label data will be used to support the new drug application for Uceris 9mg for the induction of remission of mild or moderate active ulcerative colitis.
"We are on track to submit the Uceris new drug application to the US Food and Drug Administration later this month," Ballard added.
Caption: Ulcerative colitis, a form of inflammatory bowel disease, affects an estimated 1.4 million Americans.