Santarus has commenced patient enrolment in a multicentre, randomised, double-blind, placebo-controlled Phase IIIb trial of its UCERIS (budesonide) tablets 9mg, used to treat patients with mild or moderate ulcerative colitis.
UCERIS is a locally acting (non-systemic) corticosteroid in a novel, patented, oral tablet formulation, which employs proprietary MMX multi-matrix system technology to result in the controlled release and distribution of budesonide throughout the length of the colon.
The Phase IIIb study is intended to demonstrate whether there is any benefit when UCERIS 9mg is added to current oral aminosalicylate (5-ASA) therapy for patients with active ulcerative colitis who are not adequately controlled on 5-ASA therapy.
The study will also evaluate patients who continue using their current 5-ASA treatment regimen and for an eight-week period add either UCERIS 9mg or placebo administered once daily.
In the trial, the primary endpoint includes remission at week eight, defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score of less than or equal to 1, with a zero score for rectal bleeding, stool frequency and mucosal appearance.
Santarus expects to enrol approximately 500 patients at about 120 clinical sites, with more than 50% of the sites in the US and the remainder in Canada and Europe.
Wendell Wierenga, Ph.D., executive vice president of research and development at Santarus, said: "After consulting with key opinion leaders in gastroenterology, we concluded that as the treatment paradigm for ulcerative colitis continues to evolve evaluating UCERIS as an add-on therapy is an important indication to explore."
Wierenga added: "We expect to complete patient enrolment in the Phase IIIb study in the first half of 2013."
In December 2011, the company submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking market approval for UCERIS 9mg for the induction of remission of mild or moderate active ulcerative colitis.
Santarus is a speciality biopharmaceutical company focused on acquiring, developing and commercialising proprietary products that address the needs of patients treated by physician specialists.
Image: H&E stain of a colonic biopsy showing a crypt abscess, a classic finding in ulcerative colitis. Photo: KGH.