AEterna Zentaris has reported phase 3 results for its North American efficacy trial – Z-033 and the safety trial – Z-041 in benign prostatic hyperplasia (BPH), with its compound for urology, cetrorelix pamoate.
As announced on March 6, 2009, Sanofi-aventis US entered into an agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the US market.
The first multi-center efficacy trial of Z-033 involved 667 patients in the US and Canada, with 8 additional sites in Europe. The study demonstrated no clear differences in overall efficacy with all 3 groups showing an improvement in IPSS of approximately 4 points that was maintained throughout the 52 weeks. Tolerability of cetrorelix in study was good, as evidenced by the absence of major differences to placebo with regard to both clinical adverse events or changes in laboratory parameters.
In the second study of Z-041, all patients received cetrorelix by intra-muscular injection at weeks 0 and 2, and were followed up to week 26. The primary endpoint was the incidence of possibly drug-related adverse events, efficacy parameters were evaluated as secondary endpoints.
Efficacy was assessed using the IPSS which showed an improvement from a mean score of 21.2 at baseline to 15.6 at week 26. In 63% of the patients, the improvement was by at least 3 points, said the company.
Juergen Engel, president and CEO of AEterna Zentaris, said: Although the data received for the open-label safety study Z-041 with a nearly 6 point reduction in IPSS are in line with what we had observed in our phase 2 program, we are disappointed by the failure to achieve the primary endpoint in the efficacy study Z-033. We remain committed to the ongoing phase 3 program with cetrorelix in BPH and are working towards receiving the results of the second pivotal efficacy study Z-036 in November.