In our BOSTON program, we are conducting two global phase 3 trials to study L-CsA-i in the treatment of BOS associated with lung transplantation. In parallel, we will conduct two additional supportive trials in patients with BOS.
Our BOSTON Phase 3 trials build on existing clinical experience and over 1,100 patient months of exposure with L-CsA-i. The BOSTON program is supported by leading international centers and specialists in lung transplant and allogeneic hematopoietic stem cell transplantation.
L-CsA-i has received orphan drug designation from the FDA and EMA for the treatment of bronchiolitis obliterans. Conditioned upon receiving necessary regulatory approvals, we are preparing market access and product launch plans in the U.S., EU and other global markets. Full commercial-scale production is established for L-CsA-i and the drug-specific PARI investigational eFlow® Nebulizer System.