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 optimized Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH).
Expanded Access or Compassionate Use
At this time, Breath Therapeutics, a Zambon Company, is unable to provide unapproved medicines via expanded access or compassionate use and believes that participating in its ongoing or future clinical trials is the best way to access this medicine that is not yet approved by U.S. Food and Drug Administration. We have considered many factors, including our ability to maintain supply for the ongoing and planned clinical trials, enroll and complete ongoing and upcoming clinical trials, and make reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting. In the event that Breath Therapeutics, a Zambon Company, decides to consider expanded access use for liposomal cyclosporine A for inhalation (L-CsA-i) in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.
If you or a family member are/is interested in gaining access to our investigational therapy, we encourage you to consult with your physician regarding the possibility of participating in our clinical trial. For additional information about this posted policy or if you are a treating physician requesting expanded access, please contact us via email at Breath.Patients@ZambonGroup.com. We anticipate acknowledging receipt of such inquiries sent to this email within three business days.
The posting of this policy by Breath Therapeutics, a Zambon Company, shall not serve as a guarantee of access to any specific investigational drug by any individual patient. In accordance with the 21st Century Cures Act, Breath Therapeutics, a Zambon Company, may revise this expanded access policy at any time. The policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.