Breath Therapeutics has announced the initiation of Phase 3 studies of its L‑CsA‑i inhaled liposomal cyclosporine A for the treatment of bronchiolitis obliterans. Breath Therapeutics licensed L-CsA-i from PARI in 2017, and the drug is delivered via PARI’s eFlow nebulizer.
The 48-week BOSTON-1 and BOSTON-2 studies are each expected to enroll 110 lung transplant patients and will evaluate change in lung function and time to progression of BOS. After completion of BOSTON-1 and BOSTON-2, participants will be able to continue in a planned open-label extension trial, BOSTON-3.
University of Pittsburgh Medical Center Associate Chief for Clinical Affairs Joseph M. Pilewski said, “Although lung transplant survival has improved with the advancement of surgical techniques and perioperative management, and more individuals are undergoing lung transplantation, survival has not improved to reach the rate of other organ transplantations. One key factor impacting survival in lung recipients is rejection, particularly bronchiolitis obliterans syndrome (BOS), the most common form of chronic lung allograft dysfunction. The BOSTON trials are timely and important to lung recipients and the broader lung transplant community because inhaled cyclosporine may provide the first safe and effective treatment for BOS.”
Breath Therapeutics CEO Jens Stegemann commented,”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 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.”
Read the Breath Therapeutics press release.
