Basilea reports topline results of isavuconazole phase 3 study in candidemia and other invasive Candida infections

Basilea Pharmaceutica AG / Basilea reports topline results of isavuconazole phase 3 study in candidemia and other invasive Candida infections . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, July 30, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today topline results from the phase 3 ACTIVE study. The randomized double-blind study evaluated the efficacy and safety of intravenously (i.v.) and orally administered isavuconazole versus a regimen of i.v. caspofungin followed by oral voriconazole, as a potential treatment for adults with candidemia and other invasive Candida infections.

The results showed that the study did not meet the primary objective of demonstrating non-inferior efficacy of isavuconazole versus the study comparator at the end of i.v. therapy within the pre-specified non-inferiority margin.

The overall response rates at two weeks after treatment were, however, comparable between the two treatment groups. Overall response at two weeks after treatment was the key secondary endpoint of the study. In addition, the secondary endpoint of all-cause mortality was comparable at study day 14 and day 56 in both treatment groups. The overall safety profile of isavuconazole was similar to caspofungin and consistent with safety data seen in the previously reported phase 3 studies.

Prof. Achim Kaufhold, Chief Medical Officer of Basilea, said: "We are currently reviewing the results of the study in more detail, in order to understand the totality of data to evaluate potential options for isavuconazole related to invasive candidiasis. Detailed results of the study will be submitted for presentation at scientific meetings and publications. We are also focusing on the recent positive recommendation by the European CHMP to approve isavuconazole in the area of highest medical need: the treatment of invasive aspergillosis and mucormycosis."

The overall response at the end of i.v. treatment in the modified intent-to-treat population (mITT; N=400)* was 60.3% in the isavuconazole treatment group and 71.1% in the caspofungin group with an adjusted treatment difference of -10.8% (95% CI; -19.9%, -1.8%). The lower bound of the 95% confidence interval (CI) of the treatment difference between isavuconazole and caspofungin exceeded the pre-specified non-inferiority margin of -15%.