Olorofim Aspergillus Infection Study

Inclusion Criteria:

1. Male and female patients ages over 18 years and weighing more than 30 kg

2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteriaas adapted for this study and where the duration of specific therapy for thisepisode of IA has been ≤ 28 days. For purposes of this inclusion, the duration ofspecific therapy includes any mould-active therapy given for this episode of IAwhether subsequently judged potentially effective or not.

3. Patients requiring therapy with an antifungal agent other than a mould-active azole,and who have had ≤ 96 hours of potentially effective prior therapy. Potentiallyeffective prior therapy includes any agent to which the infecting strain ofAspergillus is likely to be susceptible. There are no exclusions or limitations onsuch agents (eg, AmBisome® is permitted) other than their duration.

4. AmBisome® is an appropriate therapy for the patient.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Known history of allergy, hypersensitivity, or any serious reaction to any componentof the study drug

3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonaryaspergillosis.

4. Suspected mucormycosis (zygomycosis).

5. Patients with a known active second fungal infection of any type, other thancandidiasis that can be treated with fluconazole.

6. The requirement for ongoing use of echinocandin as Candida prophylaxis.

7. Microbiological findings (eg, bacteriological, virological) or other potentialconditions that are temporally related and suggest a different aetiology for theclinical features.

8. Human immunodeficiency virus (HIV) infection but not currently receivingantiretroviral therapy.

9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.

10. Evidence of hepatic dysfunction.