Cambridge UK, 15 March 2005: Alizyme plc (LSE:AZM) is pleased to announce that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (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 $500 million per annum. A product with a substantially improved safety/efficacy profile over existing treatments would be clinically and commercially attractive.
Commenting, Dr Richard Palmer, Chief Executive Officer 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."
For further information, please contact:
Dr Richard Palmer, Chief Executive Officer
Tim McCarthy, Finance Director
ALIZYME plc +44 (0) 1223 896000
Lisa Baderoon/Rebecca Skye Dietrich
BUCHANAN COMMUNICATIONS +44 (0) 20 7466 5000
Further information on Alizyme can be found on the Company's website: www.alizyme.com
Alizyme is a speciality pharmaceutical development company, based in Cambridge, UK, targeting the treatment and management of gastrointestinal disorders, obesity and diabetes. It has a portfolio of products which, in addition to COLAL-PREDÒ, includes renzapride (completed Phase II for irritable bowel syndrome), ATL-962 (completed Phase IIb in obese patients and currently in a Phase IIb trial in obese diabetic patients), and ATL-104 (in a Phase IIa trial for mucositis).
Inflammatory bowel disease and ulcerative colitis.
Inflammatory bowel disease ("IBD") describes two similar yet distinct inflammatory conditions, ulcerative colitis and Crohn's disease. Symptoms include abdominal pain, cramping, bleeding, diarrhoea and fatigue. Ulcerative colitis is confined to the large intestine (colon) whereas Crohn's disease also includes the small intestine.
Ulcerative colitis is a serious condition, which cannot be completely cured by current drugs and severe sufferers may eventually have to undergo surgery. Patients experience flare-ups of the disease for which the first line treatment usually involves steroids (e.g. prednisolone or prednisone). The dosage levels and the period of steroid treatment is restricted by the side effects which result from suppression of adrenal gland activity. When the inflammation subsides the patients are termed to be 'in remission', but usually need continued treatment with non-steroidal anti-inflammatory products (e.g. those based on 5-amino salicylic acid) to 'maintain' them in this state. The current drugs for 'maintenance of remission' are not completely effective and patients typically experience 1 to 2 flare-ups of active disease each year when a return to treatment with more potent anti-inflammatory drugs, such as steroids, is required.
IBD affects over two million patients worldwide, over half of whom have ulcerative colitis.
COLAL® is a drug delivery technology which enables drugs to be taken orally and then be specifically released when the preparation reaches the colon. Achieving colonic release with conventional oral dosage forms has proved difficult because of the variation between individuals in transit times and conditions within the gastrointestinal tract. COLAL® overcomes this difficulty by covering small pellets containing the drug with a coating of ethylcellulose and a specific form of amylose (derived from starch). This coating prevents drug release in the stomach and small intestine. When the pellets reach the colon the amylose in the coating is broken down by bacterial enzymes and the drug is released.
(Note: COLAL® and COLAL-PRED® are registered trademarks of Alizyme Therapeutics Limited)
The identification of compounds for successful research, their progress through development and the obtaining of regulatory approvals or authorisations before marketing, manufacture and/or distribution of products is not certain or a formality.