Breath Therapeutics has initiated a Phase III BOSTON clinical trials to evaluate the efficacy and safety of its drug candidate Liposomal Cyclosporine A for Inhalation (L-CsA-i) for the treatment of Bronchiolitis Obliterans Syndrome (BOS).
BOS is caused by T-cell mediated inflammation that leads to blockage of bronchioles, the small and medium airways in the lungs, thereby resulting in respiratory failure.
L-CsA-i is a liposomal formulation of cyclosporine A for inhalation administered through a drug-specific investigational eFlow nebuliser and has received orphan drug designation from the Food and Drug Administration and European Medicines Agency to treat BOS.
The combination of drug and device has been designed to deliver L-CsA-i to the site of disease in the lung.
The randomised, controlled trials will evaluate L-CsA-i in individuals with BOS following a single lung (BOSTON-1) or double lung (BOSTON-2) transplantation.
Breath Therapeutics CEO Jens Stegemann said: “The initiation of the BOSTON pivotal trials represents a major milestone for Breath Therapeutics and is indicative of the outstanding progress we have achieved in the past 24 months.
“We have accomplished full commercial scale production capability of both the drug and the drug-specific inhalation device, and have also assembled an exceptional leadership team to execute on our clinical development programmes and global commercialisation strategy.”
The trial’s primary endpoint is mean change in FEV1 (mL) from baseline to week 48 and the key secondary endpoints are mean change in FEV1/FVC and time to progression of the disease.
A total of 110 participants will be enrolled for each study at lung transplant speciality centres in eight countries.
Once the studies conclude, all participants will be eligible to continue in the planned open-label extension trial BOSTON-III.
For L-CsA-I, which is being developed to treat BOS in patients aged six and older, five clinical trials are currently planned or underway.