Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome.
The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer.
The Boston-1 trial is slated to enroll people with BOS who have had a single lung transplant. The company’s Boston-2 trial is designed for people with BOS who have had a double lung transplant.
The primary endpoint of the 110-person studies is the mean change in FEV1 from baseline to week 48.
“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,” CEO Jens Stegemann said in prepared remarks.
“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 programs and global commercialization strategy. Together with the enthusiasm and commitment of our renowned investigators and their teams from more than 35 of the leading lung transplant centers world-wide, we are well positioned to succeed in our goal of bringing an effective and safe treatment to people with BOS,” the chief executive added.
