Santarus, Inc. , a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products, has begun patient enrollment in a multi-centre, randomized, double-blind, placebo-controlled phase IIIb clinical study with the investigational drug Uceris (budesonide) tablets 9 mg to evaluate whether there is an incremental benefit when Uceris 9 mg is added to current oral aminosalicylate (5-ASA) therapy for patients with mild or moderate active ulcerative colitis who are not adequately controlled on background 5-ASA therapy.
The phase III b study will evaluate patients with mild or moderate active ulcerative colitis who continue using their current 5-ASA treatment regimen and for an 8 week period add either Uceris 9 mg or placebo administered once daily. The primary endpoint of the study will be remission at week 8, 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. The company expects to enroll approximately 500 patients, with 250 in each treatment arm, at approximately 120 clinical sites, with more than 50 percent of the sites in the U.S. and the remainder in Canada and Europe.
“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,” said Wendell Wierenga, PhD, executive vice president of research and development at Santarus. “We expect to complete patient enrollment in the phase III b study in the first half of 2013.”
Santarus submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in December 2011 seeking market approval for Uceris 9 mg for the induction of remission of mild or moderate active ulcerative colitis.
Uceris is an investigational drug that is a locally acting (non-systemic) corticosteroid in a novel, patented, oral tablet formulation, which utilizes proprietary MMX multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. According to the Crohn's & Colitis Foundation of America, IBD affects an estimated 1.4 million Americans.