Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olorofim · 3 trials · 10 indications
To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
Change from baseline in VF-PRO Mobility domain score at the Day 168 (Week 24) study visit.
Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit.
| Arm | Type | Description |
|---|---|---|
| Olorofim | ACTIVE_COMPARATOR | Olorofim versus AmBisome followed by Standard of Care (SOC) |
| AmBisome | ACTIVE_COMPARATOR | Olorofim versus AmBisome followed by Standard of Care (SOC) |
| Olorofim (F901318) | EXPERIMENTAL | Olorofim (F901318) was given orally for up to 90 days in the Main Study Phase and could be continued for those participants entering the Extended Treatment Phase. Patients received fixed doses comprising of a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day. Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg. |
| Arm A (olorofim, plus Standard of Care) | ACTIVE_COMPARATOR | Arm A: receives oral olorofim + Standard of Care |
| Arm B (placebo comparator, plus Standard of Care) | PLACEBO_COMPARATOR | Arm B: receives olorofim-matched placebo + Standard of Care |
| Name | Type | Description |
|---|---|---|
| Olorofim | DRUG | Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days) |
| AmBisome® | DRUG | Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling. |
| Placebo | DRUG | Arm B: Oral olorofim-matched placebo loading dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 followed by a maintenance dose of 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 168 (± 7 days) |
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 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For ...
Olorofim is an investigational small molecule being studied for the treatment of invasive fungal infections, including invasive aspergillosis and coccidioidomycosis (Valley fever). It is being evaluated in patients with limited treatment options and in those with progressive or refractory disseminated coccidioidomycosis.
Olorofim is being developed by IQVIA Holdings, Inc. (ticker: IQV). The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating serious fungal infections.
Olorofim is in Phase 2 and Phase 3 clinical development. It is not approved by the FDA and remains investigational. Trials include a Phase 2 study for invasive fungal infections, a Phase 3 study for invasive aspergillosis, and a Phase 2 study for coccidioidomycosis.
Olorofim is being studied in three trials: NCT03583164 (Phase 2, invasive fungal infections, completed), NCT05101187 (Phase 3, invasive aspergillosis, active), and NCT07712484 (Phase 2, coccidioidomycosis, not yet recruiting). These trials are conducted across multiple countries.
Yes, Olorofim is also known as F901318. The Phase 2 trial NCT03583164 is titled 'Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options,' confirming that F901318 and Olorofim refer to the same drug.