The trial is a multi-centre, randomized, double-blind, placebo-controlled, parallel design, dose ranging study of COLAL PRED® for the treatment of ulcerative colitis in approximately 200 patients. Patients will be randomized to placebo or one of four doses of COLAL PRED® (equivalent to 40, 60, 80, or 120 mg of prednisolone) for a treatment period of 4 weeks.
Alizyme is currently developing COLAL-PRED® for the treatment of ulcerative colitis in Europe. Recruitment into the current EU Phase III registration clinical trial in approximately 800 patients with active moderate-to-severe ulcerative colitis completed in 2007 and headline results are expected to be reported in July 2008. Successful results from this EU Phase III trial would allow a Marketing Authorisation Application (“MAA”) to be submitted for the EU in Q4 2008.
Commenting on today’s announcement, Tim McCarthy, Alizyme’s Chief Executive Officer said:
“We are delighted with the news that Prometheus has initiated recruitment into their Phase II study for COLAL-PRED® in the US, a significant market for this product. The commencement of clinical activity in the US for COLAL-PRED® is a key milestone in the development and commercialisation of this product for the global market.
