Clinical Trials

Date: 2014-10-16

Type of information: Submission of a clinical trial application

phase: 3

Announcement: submission of a clinical trial application

Company: Basilea Pharmaceutica (Switzerland) Astellas Pharma (Japan)

Product: Cresemba® (isavuconazole)

Action mechanism:

systemic antifungal agent. Isavuconazole is an investigational intravenous and oral broad-spectrum antifungal. It has a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of the enzyme lanosterol 14 alpha demethylase. In collaboration with Astellas Pharma Inc., isavuconazole is being investigated in phase 3 clinical studies for the treatment of severe invasive fungal infections. The drug demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as in-vitro activity against less prevalent but often fatal molds including those that cause mucormycosis. In clinical studies to date, isavuconazole achieved predictable drug levels supporting reliable dosing and a switch from intravenous administration to a once-daily oral dose. The intravenous formulation of isavuconazole, which is water-soluble, does not contain potentially kidney damaging solubilizers and has the potential to be given also to patients with pre-existing renal impairment.

Disease: candidemia and other invasive Candida infection

Therapeutic area: Infectious diseases

Country:

Trial details:

The phase 3 ACTIVE study is evaluating the safety and efficacy of intravenously (i.v.) and orally administered isavuconazole versus i.v. administered caspofungin followed by oral voriconazole in the treatment of candidemia and other invasive yeast infections caused by Candida spp.

Latest news:

• On October 16, 2014, Basilea Pharmaceutica announced that its partner Astellas Pharma has filed an amendment to the phase 3 ACTIVE study protocol with the relevant health authorities and ethics committees. The study assesses the investigational antifungal isavuconazole in the treatment of candidemia and other invasive Candida infections. In the protocol amendment, the targeted patient number will be reduced from 526 to 438 which will allow an earlier finalization of the study. A blinded assessment of the overall subject evaluability rate based on the available study data estimates a higher rate of evaluable patients than originally expected. This allows for a reduction in patient numbers while preserving sufficient statistical power for the primary objective of demonstrating non-inferiority in overall response rates at the end intravenous treatment between isavuconazole and caspofungin.
The protocol amendment is subject to regulatory and ethic committee approval.