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Release issued 16th October 2000
Alizyme plc ("Alizyme") today announces the preliminary results from its Phase IIa pilot clinical trial of ATL-1251 (renzapride) in constipation- predominant irritable bowel syndrome (IBS) patients. ATL-1251 showed improvement of a number of symptoms associated with this condition, when compared to placebo, and was generally well tolerated.
The trial objectives were to assess efficacy, tolerability and safety of ATL-1251 in this patient population. The single blind trial, which was placebo-controlled, was carried out at two centres in the UK and two in Belgium and enrolled 20 patients of whom 40% were male. It comprised four weeks dosing on placebo, followed by four weeks on a single daily dose of ATL-1251 and then escalating for a further four weeks twice daily dosing in each patient.
The efficacy of ATL-1251 was evaluated by assessing colonic motility and gastrointestinal transit time, determined radiographically, and symptoms associated with constipation-predominant IBS.
IBS is a complicated syndrome with patients displaying a variety of symptoms. Although this trial was not designed to be statistically powered, both colonic motility and gastrointestinal transit time were improved, with an indication of dose-dependence, in more than 70% of patients who showed impaired motility. In addition, over 50% of patients showed improvements over placebo in a number of symptoms, including abdominal pain and discomfort. Improvements in symptoms were seen at similar frequencies in both male and female patients.
ATL-1251 was generally well tolerated and no ECG abnormalities were observed in the patients in this study.
Dr Richard Palmer (Chief Executive Officer) commented:
"We are very pleased to have obtained proof of concept for ATL-1251 in constipation-predominant IBS patients. The results of this pilot study are in line with expectations and are consistent with the data from the Phase I programme. We look forward to planning a Phase IIb, statistically powered clinical trial to define the optimal dose for this IBS patient population and potentially, to evaluating ATL-1251 for the treatment of patients with mixed-symptom IBS."
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