Zambon has completed the patient enrolment of patients in its two pivotal Phase III trials of Liposomal Cyclosporine A for Inhalation (L-CsA-i) to treat bronchiolitis obliterans syndrome (BOS).
Designed to assess the safety and efficacy of L-CsA-i, the trials have enrolled adults with BOS following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation.
A total of 231 patients from Europe, Israel and the US were enrolled for both the studies and 42 lung transplant centres have participated altogether.
Zambon chief medical officer and R&D head Paola Castellani said: “The completion of enrolment in our Phase III BOSTON-1 and BOSTON-2 studies represents a significant milestone for Zambon and the patient community we aim to serve.
“On behalf of the company, we would like to thank the many participants in our Phase III clinical programme, as well as our study sites and investigators for their commitment. We look forward to reporting top-line results from the programme during 2024.”
The company also plans to initiate an extension study, BOSTON-3, and enrol eligible patients who complete both trials.
An inhaled therapy, L-CsA-i is administered using the optimised investigational eFlow Technology nebuliser system, developed by PARI Pharma.
A rapidly progressive inflammatory rare disease, BOS irreversibly destroys the lungs’ airways leading to respiratory failure and death within two to four years following diagnosis.