Rezafungin for treatment of CPA in adults with limited treatment options
Research type
Research Study
Full title
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 (MR907-2502)
IRAS ID
1011377
Contact name
Terry Nichols
Contact email
Sponsor organisation
Mundipharma Research Limited
Clinicaltrials.gov Identifier
Research summary
Chronic pulmonary aspergillosis (CPA) is a progressive an in many cases, potentially life-threatening fungal infection of the lungs. The disease is quite rare, affecting approximately less than 1 in 100,000 people in the UK and Europe. For these patients, one of the main factors of disease progression is rapid deterioration of the lungs which severely impacts quality of life and has a 14% mortality rate. Only very limited treatment options are available, such as a group of medications known as azoles, or Intravenous (IV medications known as amphotericin B or echinocandins). These treatments are not always practical or tolerated by these subjects due to the patient being resistent (ie azole resistance), or long term treatment not practical due to daily intra-venous (IV) infusions being required on a long term basis, and the associated risks and safety concerns of the longer term administration of these. This study aims to assess the effectiveness and safety of an alternative treatment known as rezafungin, which is administered intravenously once per week. All eligible subjects will be asked to attend a screening visit, to gather baseline data and perform tests such as blood tests, questionnaires, medical history and medication review. Two CT Scans will be performed either during the screening period or at the next visit (baseline visit) and at week 28. Two weeks after the screening visit, if still eligible, the subjects start a 6 month treatment period of IV infusions of rezafungin which will be administered each week for 26 weeks. Further questionnaires/assessments are carried out at the baseline visit and week 13. Further blood tests will be performed at some of the visits during the 6 month treatment period. The subjects will be asked to report all adverse events throughout the study and these will be documented accordingly by the study team. Following this, an end of treatment visit will take place a week later, then a follow up visit 3 weeks after.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0206
Date of REC Opinion
15 Apr 2025
REC opinion
Further Information Favourable Opinion