Alizyme obtains PIII trial for ulcerative colitis
Alizyme, from Cambridge, has received approval from the MHRA for a pivotal Phase III clinical trial of Colal-Pred for the treatment of patients with acute ulcerative colitis.
Alizyme, from Cambridge, has received approval from the MHRA for a pivotal Phase III clinical trial of Colal-Pred for the treatment of patients with acute ulcerative colitis.
The trial will be a randomised, double-blind, active comparator controlled, parallel-group study and will seek to demonstrate similar efficacy of Colal-Pred to conventional oral prednisolone, but with a substantially improved side effect profile. The trial will involve up to 670 patients who have moderate to severe ulcerative colitis. Patients will undergo eight weeks of treatment and a four-week follow-up period. In addition to the UK, the trial is planned to be conducted in a number of other European countries.
Assuming the clinical endpoints and recruitment timelines are met, Alizyme expects to make an application for marketing authorisation of Colal-Pred during 2007.
Colal-Pred comprises a prednisolone derivative (prednisolone sodium metasulphobenzoate) in Alizyme's proprietary colonic drug delivery technology, Colal. Data from Alizyme's Phase II trial with Colal-Pred, indicated 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 $500m per annum. A product with a substantially improved safety/efficacy profile over existing treatments would be clinically and commercially attractive.
Commenting, Dr Richard Palmer, ceo said: 'We are extremely pleased to receive regulatory approval for this pivotal registration Phase III clinical trial of Colal-Pred in Europe. Our extensive discussions with European regulators have concentrated on agreeing detailed aspects of the clinical and safety endpoints and their statistical analysis. 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.'