The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Inclusion Criteria:

1. Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

1. Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
2. Participant who has previously received PC945.
3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis

Double Blind

The Sponsor has exclusive rights to the first publication via a multi-center study publication. Institutions and Investigators may publish independently only after the multi-center publication or 12 months (Sponsor's template language, for use where there is no mandated national CTA) after study completion. Independent submissions require 60 days' Sponsor review, a possible 45-day delay for IP protection, removal of confidential information, and good-faith consideration of Sponsor comments.