Alizyme terminates development of irritable bowel syndrome drug

The Phase III study compared renzapride 4mg once a day, renzapride 2mg twice daily and placebo, dosed for 12 weeks, in women with irritable bowel syndrome (IBS-C). Approximately 1,821 patients were randomized, of whom 1,798 were eligible for inclusion in the ‘intention-to-treat’ 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%.

Based on the adequacy of the study itself, together with the 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.

Tim McCarthy, CEO of Alizyme, said: “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. We will focus our resources on the other three products in our product portfolio and on the commercialization of these late-stage assets.”