- Basilea Pharmaceutica has revealed positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE).

The antifungal agent isavuconazole is being co-developed with Astellas Pharma Inc.

The randomized, double-blind isavuconazole study (SECURE) achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi.

Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population (N=516).

The all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.

In addition, the key secondary endpoint of overall success rate (composite of clinical, mycological, radiological responses) at the end-of-therapy in patients with proven/probable disease was similar between isavuconazole and voriconazole (35.0% and 36.4%, respectively).

This outcome was based on a blinded assessment by the independent data review committee.

Overall drug and non-drug-related adverse events were reported in 96.1% and 98.5% of patients in the isavuconazole and voriconazole treatment groups, respectively.

The most frequent adverse events reported were nausea, vomiting, pyrexia (fever), diarrhoea, and hypokalaemia (deficiency of potassium in the blood) which were reported at similar rates in both treatment groups.

Study drug-related adverse events were reported in 42.4% and 59.8% of patients in the isavuconazole and voriconazole treatment groups, respectively.

Basilea's CEO Ronald Scott commented: "The successful completion of this study is a major achievement and an important milestone for our company. Invasive aspergillosis is a life-threatening disease primarily afflicting immunocompromised patients.

"There is a great medical need for new antifungal agents to treat these critically ill patients. The results from this isavuconazole study (SECURE) represent an important step in the development of this potential new treatment option for patients suffering from invasive aspergillosis."

Story provided by