NCT06794554

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options. The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging. Participants will: * Be given the drug rezafungin every week for 6 months. * Visit the clinic once a month for checkups and tests. * Complete questionnaires on thier health and wellbeing.

Detailed description

Chronic pulmonary aspergillosis (CPA) is a progressive and potentially life-threatening fungal infection of the lungs. It is usually, but not exclusively, caused by Aspergillus fumigatus and affects patients with underlying respiratory disorders with a prevalence of less than 1 per 100,000 in Europe. The disease leads to the destruction of lung tissue typified by the insidious enlargement of cavities and fibrosis which can severely impact quality of life and has a mortality of up to 14% in one year. The only approved class of oral antifungals are the azoles such as voriconazole or itraconazole. Treatment with azoles is for a minimum of six months, however, in practice can be long-term and, in some cases, lifelong. Azole resistance can often be attributed to the suboptimal treatment response rates in CPA. This is possibly a consequence of accumulations of the Aspergillus fungus that form 'aspergillomas' which harbour high concentrations of the fungus, thus driving the propensity to develop resistance. The resistance to one azole can often be associated with pan-azole resistance resulting in a lack of effective oral treatment options. In addition to drug resistance, azoles are potentially hepatotoxic, can elicit adrenal suppression and neuropathy. One of the main safety concerns with voriconazole is that it has been linked to skin cancer. If azole therapy is not an option due to intolerance or resistance, patients are left with Intravenous (IV) amphotericin B (which due to toxicity can only be given short-term) or IV echinocandins. Currently licensed IV echinocandins need to be given daily which limits the practicality of longer-term therapy. This proposed study aims to generate clinical data on the efficacy and safety of rezafungin for treatment of CPA.

Conditions

• Chronic Pulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	Rezafungin Acetate	IV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 26 doses (6 months).

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-01-27
• Last updated: 2025-08-29

Locations

37 sites across 10 countries: Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, South Korea, Spain, United Kingdom