July 6 2007 | Category: Product
Bunnik, The Netherlands, 9 July 2007. AM-Pharma B.V., the biopharmaceutical company developing novel therapeutics to treat infectious and inflammatory diseases, today announced the positive clinical results of its Phase IIa Alkaline Phosphatase (AP) trial for patients with ulcerative colitis, a chronic and relapsing inflammatory bowel disease affecting the colon.
In this recent trial, AP was used in the treatment of 21 hospitalised patients suffering from moderate to severe ulcerative colitis, who had failed to show improvement using existing treatments of steroids and immunosuppressants. The AP therapy was administered through a duodenal drip at a dose of 10mg AP per day.
In the trial, patients showed clinically relevant improvement after the seven day treatment period, in the two main clinical parameters (Truelove-Witts and Mayo scores) measured three weeks after starting the AP trial.
Patient response rates after three weeks were 63% on the Truelove-Witts score and 47% on the Mayo score. Complete remission after three weeks was reached by 21% of patients on the Truelove-Witts score and by 5% of patients on the Mayo score. After 63 days, 79% of patients showed a response and 26% of patients were in complete remission according to the Truelove-Witts score. No serious adverse effects or treatment-related withdrawals were reported.
AP is a unique therapy for ulcerative colitis based on the dephosphorylation and detoxification of a group of bacterial endotoxins called lipopolysaccharides, which can cause inflammation in the colon. AM-Pharma’s patented AP treatment has already shown positive results in trials for treatment of acute renal failure and sepsis.
Bart Wuurman, CEO commented: “It’s fantastic that this first AP study for ulcerative colitis revealed our treatment to be clinically active, despite the short seven day treatment period and the severity of the patients’ disease. These results are very promising for the future development of AP for ulcerative colitis, where we plan to administer AP treatment for longer periods. Also importantly, results from this trial revealed that the treatment is very well tolerated. This is potentially good news for ulcerative colitis sufferers, who are looking for safe and effective treatment options.”
AM-Pharma will continue to study the oral use of AP for ulcerative colitis in a further Phase II clinical study. Once safety and efficacy have been confirmed in a larger group of patients, AM-Pharma
intends to license the product to a partner who will take on the late-stage development and worldwide commercialisation of AP.