Vical has started a Phase II trial to compare the efficacy and safety of VL-2397 to standard treatment for acute leukemia patients with invasive aspergillosis and recipients of an allogeneic hematopoietic cell transplant (HCT).
The multicentre, open-label randomised clinical study aims to enrol around 200 patients. It will be carried out at selected sites in North America, Europe, and Asia.
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During the trial, patients will be randomised on a 2:1 basis with about 134 patients treated with VL-2397 and 66 patients treated with a standard six-week course of their physician’s choice of voriconazole, isavuconazole, or liposomal amphotericin B.
The patients in the VL-2397 group will be given daily treatment of VL-2397 for four weeks, followed by a two-week course of physician’s choice of the comparator.
The trial’s primary endpoint is all-cause mortality at four weeks, while the major secondary endpoint is the same state at six weeks.
Vical president and CEO Vijay Samant said: “The limited population pathway enables Vical to develop and potentially commercialise VL-2397 on an accelerated basis for a limited-use indication, and we are pleased that the Phase II trial is now underway.
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By GlobalData“New antifungals, especially with novel mechanisms of action, are desperately needed to enhance treatments options when currently marketed therapies are inadequate due to their associated toxicities, drug-drug interactions, and the emergence of azole-resistant strains.”
The US Food and Drug Administration (FDA) has recommended that VL‑2397 would be eligible for a limited-use indication (LUI), provided the successful completion of a single Phase II trial that should be conducted following a protocol and statistical analysis plan consistent with FDA’s advice.
LUI is a provision of the limited population pathway recognised under the 21st Century Cures Act of 2016.
