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Alizyme plc announces clinical trial results from Study 038, its Phase III study of renzapride in constipation-predominant irritable bowel syndrome
CAMBRIDGE, UK | April 23, 2008 | Alizyme plc ("Alizyme" or "the Company") (LSE: AZM) announces clinical trial results from Study 038, its Phase III study of renzapride in constipation-predominant irritable bowel syndrome ("IBS-C").
-- Statistical significance achieved on the primary endpoint (duration of relief of overall IBS symptoms)
-- Treatment groups showed limited clinical improvement over placebo group
-- Limited effects seen on the three key secondary endpoints (relief of pain, bowel problems and bloating)
-- No safety or tolerability issues
-- Results do not justify further development of renzapride by Alizyme
The Phase III study compared renzapride 4mg once a day, renzapride 2mg twice daily and placebo, dosed for 12 weeks, in women with IBS-C. 1,821 patients were randomised, of whom 1,798 were eligible for inclusion in the 'intention-to-treat' ("ITT") population.
Both renzapride patient groups showed a statistically superior response compared to placebo on the primary endpoint (the number of months for which a patient was a responder). The proportion of patients who reported at least some improvement in their overall symptoms were about 60% in the two renzapride patient groups compared to about 55% in the placebo patient group each week, with an average increase over the placebo group of 5-6%.
Limited effects were seen on the three key secondary endpoints; those being relief of abdominal pain, relief of bowel problems and relief of bloating.
Data from the Phase II programme provided strong evidence of the pro-kinetic effect of renzapride through increased frequency of bowel movements and improved stool consistency. The Phase II programme also showed evidence of adequate relief of abdominal pain. These outcomes contrast with the data seen in this Phase III study.
As in the Phase II programme, there were no safety or tolerability issues observed in the Phase III study.
The Company believes this Phase III study was well designed to detect any durable benefits of renzapride versus placebo in a large patient population with IBS-C. Based on the adequacy of the study itself, together with today's clinical results, the Company considers that the efficacy shown is not sufficient to justify further development of renzapride by Alizyme. As a result, the Company is discontinuing clinical development of renzapride, including Study 052, the on-going open label extension study to evaluate the long-term safety and tolerability of renzapride.
Commenting on today's announcement, Tim McCarthy, Chief Executive Officer, of Alizyme said:
"We are disappointed with the outcome of this Phase III clinical study for renzapride. Data from our Phase II clinical programme provided a strong basis for progressing to the Phase III development of this compound for the management of IBS. Although in this Phase III study, renzapride has demonstrated some therapeutic benefit and was shown to be safe, the results do not provide sufficiently compelling data to justify further development by Alizyme.
Following today's announcement we will focus our resources on the other three products in our product portfolio and on the commercialisation of these late-stage assets."
SOURCE: Alizyme plc
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