Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy

Conditions

• Invasive Mould Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EL219 — DRUG
  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.
• Active Comparator- IV Antifungal (LAmB or voriconazole) — DRUG
  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.

Study Details

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

Key Dates

Start date

Feb 13, 2026

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EL219
  Participants randomized to EL219 will receive a single loading dose of EL219 at 2 mg/kg via IV infusion on Day 1, and 1.5 mg/kg IV infusions on Days 8, 15, 22, 29, and 36. All dosing calculations for EL219 will be based on total body weight (TBW). To maintain the blind, placebo IV infusions will be administered to participants randomized to EL219 arm daily (corresponding to Liposomal Amphotericin B (LAmB) dosing); or 2x daily (corresponding to voriconazole dosing depending on the Investigator's choice of Comparator).
• Active Comparator: Antifungal Comparator
  Comparator arm (CMPTR) will receive LAmB 3mg/kg once daily IV infusions for min.14 days \& up to 42 days. Participants w/suspected or diagnosed mucormycosis may be dosed at 5mg/kg. Voriconazole (Vori) 6mg/kg BID IV loading dose on Day 1 followed by 4mg/kg IV BID thereafter. Dosing calculations for LAmB \& vori are based on TBW. Participants may switch from CMPTR to optional SOC antifungals (PI discretion) if any of these occur: Toxicity; serum creatinine 2×baseline (bsln) level or 50% reduction in GFR, Hypokalemia or hypomagnesemia not controlled with IV supplementation, increase in ALT to 3×bsln and/or total bili 3×bsln, intractable IRR •Imminent hosp discharge requiring switch from CMPTR •Intolerable clinical s/s consistent w/known drug-related effect •Dx by C\&S testing suggesting IMI not appropriately treated w/1 or both CMPTR drug Vori trough level \<2.0 or \>5.5mg/L for whom vori was selected as the randomized CMPTR

Primary Outcome Measure

Primary Outcome/Measure All-Cause Mortality [ Time Frame: From enrollment to Day 21 ]

Central Contacts

• Laura A. Navalta
  443-423-1785
  [email protected]
• Gordana Schnider, MHA
  443-423-1785
  [email protected]

Locations (5)

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