Basilea Pharmaceutica AG, of Basel, Switzerland, completed recruiting patients for a Phase III pivotal trial of its antifungal agent, isavuconazole. With partner Astellas Pharma Inc., Basilea is studying safety and efficacy of once-daily isavuconazole compared to twice-daily voriconazole for up to 84 days of treatment in infections caused by Aspergillus or other filamentous fungi.

Invasive yeast and mold infections caused by Candida and Aspergillus species are potentially life-threatening, and are a significant cause of morbidity and mortality in immunocompromised patients, such as those with cancer.

Mortality for invasive aspergillosis ranges from 40 percent to 80 percent, according to Basilea's head of public relations and corporate communication, Peer Nils Schroder. "The total market for invasive fungal infections is estimated to exceed $3 billion," Schroder told BioWorld Today.

A total of 527 patients have been enrolled for the study, designated SECURE, and the results are expected in the second half of 2013.

In addition, Basilea has reached target enrollment for its VITAL study, an open-label, Phase III study of isavuconazole for aspergillosis in patients with renal impairment or those with invasive fungal disease caused by molds, yeasts or dimorphic fungi.

The ACTIVE Phase III study of isavuconazole I.V. and oral compared to caspofungin I.V. followed by oral voriconazole for Candida infections continues to recruit. That process is expected to go on into 2014.

Isavuconazole is a member of the azole class of drugs, and its safety profile is expected to be comparable to those drugs.

Previous preclinical and clinical studies show that I.V. and oral isavuconazole may have potential to overcome limitations of currently available treatments.

Other antifungals, such as voriconazole, have significant side effects and drug interactions, a particular problem in populations of patients who are generally already seriously ill and immune-compromised.

Isavuconazole has fast-track status in the U.S., with potential for expedited review.

Now that study recruitment is complete for the Phase III trial, results are expected in the second half of 2013.

Little competition exists in the drug space. Pfizer Inc.'s Vfend (voriconazole) dominates the market, earning $800 million per year, and the generic fluconazole has a large market share, as well.

One up-and-comer is an investigational compound in development by F2G Ltd., of Manchester, UK. F2G is preparing to move the compound, FG3622, into first-in-human studies. (See BioWorld Today, Sept. 12, 2012.)

Basilea partnered with Astellas Pharma Inc. in 2010 in a deal that paid CHF75 million (US$69.6 million) up front and up to CHF478 million more in development and sales milestones in exchange for worldwide rights to isavuconazole, except for Japan.

Basilea's pipeline also includes clinical stage antibiotic candidates ceftobiprole and BAL30072, oncology compound BAL101553 and some preclinical programs. It markets Toctino (alitretinoin) for chronic hand eczema.