Elion Therapeutics, Inc.
The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections
A Phase 2, multicenter, randomized, double-blind Study of Safety and Efficacy of EL219 versus Comparator (LAmB or voriconazole) for early antifungal therapy of suspected or confirmed Invasive Mould Infections (IMI)
Inclusion Criteria: Participants who meet ALL the following inclusion criteria will be eligible to participate in the study: 1. Willing and able to provide written informed consent. 2. 18 years and older, of any gender, race, or ethnicity 3. Are at risk for invasive fungal infections (IFIs), by virtue of acquired or inherited immunocompromising condition including but not limited to the following: 1. Receipt of a blood or marrow transplant (BMT) from an allogeneic donor 2. Active hematologic malignancy. 3. Recent neutropenia with absolute neutrophil count \<500 cells/mm3 \>10 days…
EL219 is specifically being developed for early antifungal therapy (EAT), when infection is suspected due to highly suggestive signs and symptoms of disease; in high-risk people, antifungals are recommended even before confirmation of the microbial cause of infection, because delayed therapy is associated with poor outcomes in those who lack adequate immune responses. EL219 may provide a once-weekly alternative to LAmB and other polyenes that could also reduce the toxicities that often limit the frequency and duration of administration for these highly efficacious antifungals.
LAmB has broad-spectrum activity but its use is limited by toxicity and once-daily IV administration. It is not administered outside of the monitored setting given risks for electrolyte disturbances and cardiac arrhythmias. Voriconazole is a first-line therapy for IA and the most common azole used in the US and globally but does not have activity against many non-Aspergillus moulds.