Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis

The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).

Main Inclusion Criteria:

• Patients must have the below proven, probable or possible deep mycosis;

  1. invasive aspergillosis
  2. chronic pulmonary aspergillosis
  3. mucormycosis
  4. cryptococcosis

• Female patients must be non-lactating and at no risk for pregnancy.

Main Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
• Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
• Patients with a history of short QT syndrome.
• Patients with liver dysfunction at enrollment.
• Patients with moderate to severe kidney dysfunction at enrollment.
• Patients who receive prohibited concomitant drugs.
• Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species.
• Patients who are not expected to survive study duration.
• Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
• Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
• Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.