An independent data safety monitoring board has given its thumbs up to the continuation of a Phase III study of Basilea Pharmaceutica's isavuconazole for the treatment of invasive Aspergillus infections.
The primary goal of the study is to demonstrate the non-inferiority of isavuconazole compared with the current standard-of-care, Pfizer's voriconazole. A futility analysis was included in the clinical trial design to ensure that the trial could be stopped early if it appeared that the study wouldn't be able to demonstrate non-inferiority. The board's recommendation was based on the analysis of the primary efficacy endpoint of 180 patients.
"The recruitment of new patients into the Phase III clinical program is expected to resume in the first half of 2010 and topline data are anticipated to be available in 2011," Basilea CEO Anthony Man says in a statement.
Investigators also are studying isavuconazole as a treatment for yeast infections, as well as mold infections. Swiss-based Basilea is also seeking approval in the EU and U.S. for ceftobiprole, a broad-spectrum antibiotic to fight hospital superbugs, with U.S. partner Johnson & Johnson, Reuters notes.
Basilea recently claimed it has been hurt after the FDA told J&J that it cannot approve a NDA for ceftobiprole in its present form, according to Pharma Times. Ceftobiprole was once regarded as a potential market winner with projected annual sales of $300 million, but now it probably won't hit the market for several years.
- check out the Basilea release
- see the Reuters coverage
- read the Pharma Times story