UK biotechnology company, Alizyme, has received a boost on news that the UK regulator, the Medicines and Healthcare products Regulatory Agency, has given the nod for the firm to begin a pivotal Phase III clinical trial of Colal-Pred for the treatment of patients with acute ulcerative colitis.
The study will involve up to 670 patients with moderate to severe ulcerative colitis and aims to assess the drug’s efficacy versus conventional oral steroid drug prednisolone. Patients will undergo eight weeks of treatment and a four-week follow-up period.
Assuming the clinical endpoints and recruitment timelines are met, Alizyme expects to file Colal-Pred for regulatory approval during 2007. Richard Palmer, Alizyme’s chief executive officer, commented: “In accordance with our discussions with the regulators, successful completion of this one single study would be sufficient to allow for initial registration and commercialisation in Europe.”
Colal-Pred comprises a prednisolone derivative in Alizyme’s colonic drug delivery technology, Colal. Phase II data have shown that through the local delivery of this drug, the undesirable side effects such as immuno suppression, associated with the use of steroids are avoided.
The worldwide market for ulcerative colitis drugs is estimated to be worth at least $500 million dollars each year, and Alizyme notes that a product with a substantially improved safety/efficacy profile over existing treatments would be clinically and commercially attractive.