Zambon has announced that the Phase 3 BOSTON-1 and BOSTON-2 trials of liposomal cyclosporine A for inhalation (L-CsA-i) have completed enrollment. The two trials were initiated by Breath Therapeutics in March 2019 prior to that company’s acquisition by Zambon. Breath Therapeutics was spun off from PARI Pharma in 2017 to develop L‑CsA‑i, which has received Fast Track and Orphan Drug designations from the FDA.
BOSTON-1 is evaluating L-CsA-i for the treatment of BOS following single lung transplantation, and BOSTON-2 is evaluating the nebulized formulation for the treatment of BOS following double lung transplantation. According to Zambon, the studies together enrolled a total of 231 lung transplant patients. The company noted that the BOSTON-3 extension study will be open to participants from both the BOSTON-1 and BOSTON-2 studies.
Zambon Chief Medical Officer and R&D Head Paola Castellani commented, “The completion of enrollment in our Phase 3 BOSTON-1 and -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 3 clinical program, as well as our study sites and investigators for their commitment. We look forward to reporting top-line results from the program during 2024.”
CEO Ilaria Villa said, “At Zambon, we are committed to advancing new therapeutic options that have the potential to make lives better for people affected by severe respiratory diseases such as BOS. The completion of enrollment in our pivotal trials brings us one step closer to our goal of bringing a much-needed therapy to the lung transplant recipients worldwide with BOS.”
Read the Zambon press release.
