In the BOSTON program, we are currently conducting two global pivotal phase 3 studies to evaluate the efficacy and safety of L-CsA-i for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation. The BOSTON pivotal studies build on existing clinical experience and over 1,100 patient months of exposure with L-CsA-i.
BOSTON-3 is an open-label extension study for eligible participants who complete the BOSTON-1 and BOSTON-2 studies. BOSTON-4 is currently underway and will assess the safety and exploratory efficacy in adults with BOS following allogeneic hematopoietic stem cell transplant (alloHSCT). BOSTON-5 is a planned safety study in pediatric patients with BOS.
L-CsA-i has received orphan drug designation for the treatment of BOS from the US Food and Drug Administration and European Medicines Agency.
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 being established for L-CsA-i and the drug-specific Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH).