A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 Versus Standard of Care (Liposomal Amphotericin B Followed by Voriconazole) for Early Antifungal Therapy of Suspected Invasive Mould Infections
The purpose of this study is to determine if EL219 is safe and effective compared to the standard of care for early treatment of suspected invasive mould infection.
∙ Participants who meet ALL the following inclusion criteria will be eligible to participate in the study:
• Willing and able to provide written informed consent.
• Males or females 18 years and older,
• Are at risk for invasive fungal infections (IFIs), with one of the following:
‣ Receipt of a bone marrow transplant (BMT) from an allogeneic donor, with blood, bone marrow, or cord blood as stem cell source.
⁃ Receiving or have recently (within 1 month) received cytotoxic, biologic, or immune modulating therapy(ies) for hematological malignancy.
⁃ Receipt of corticosteroids at mean minimum doses of 0.3 mg/kg/day prednisone equivalent for more than 3 weeks.
⁃ Receipt of other recognized T-cell immunosuppressants, such as cyclosporin, tumor necrosis factor alpha (TNF-α) blockers, or specific monoclonal antibodies during the last 3 months.
⁃ Inherited severe immunodeficiency
∙ Has suspected invasive mould infection (IMI) as defined by one or both of the following:
• Results of an assay having regulatory clearance in Europe or the United States (Conformité Européene \[CE\] mark or United States Food and Drug Administration \[US FDA\] 510k clearance), demonstrating positivity at validated cut-off that is suggestive of IMI, but does not meet microbiologic criteria for probable invasive aspergillosis (IA; as defined by 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 \[EORTC/MSG\]). Diagnostic tests must have regulatory approval in the region in which the diagnostic is performed and are inclusive of Platelia serum galactomannan, serum or bronchoalveolar lavage (BAL) polymerase chain reaction (PCR), serum or BAL Aspergillus antigen lateral flow assays (LFAs; IMMY, OLM Diagnostics, or TECO®), or urine MycoMEIA®-Aspergillus assay
• Abnormal findings on chest computed tomography (CT) scan without alternative microbiologic diagnosis Note: If CT of the chest is used to establish eligibility it must be performed within 7 days prior to randomization.
• 5\. Must have IV access in place or to be placed prior to beginning IV study therapy.
• 6\. Must be willing to adhere to dosing, study visit schedule, and mandatory diagnostic procedures.
• 7\. Female participants must meet 1 of the following criteria: A woman of childbearing potential (WOCBP) must agree to use a highly effective, preferably user-independent method of contraception (failure rate of \<1% per year when used consistently and correctly) for at least 30 days prior to screening and agree to remain on a highly effective method until 2 months after study drug administration.
• 8\. A WOCBP must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before study drug administration.
• 9\. Females must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 2 months after study drug administration.
• 10\. Male participants must be vasectomized or agree to abstain from intercourse or if engaging in sexual activity that has risk of pregnancy, must agree to use a double barrier method and agree not to donate sperm during the study and for at least 120 days after study drug administration.