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.
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.
“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.