Breath Therapeutics, which was acquired by Zambon in July 2019, said that it has initiated two new trials of its liposomal cyclosporine A for inhalation (L-CsA-i) for the treatment of bronchiolitis obliterans syndrome (BOS). BOSTON-3 is open-label extension study of the Phase 3 BOSTON-1 and BOSTON-2 studies of L-CsA-i for the treatment of BOS after a lung transplant which were initiated in March 2019. BOSTON 4 is a Phase 2 study of L-CsA-i for the treatment of BOS after allogeneic hematopoietic stem cell transplant (alloHSCT).
L-CsA-i is delivered via a PARI investigative eFlow nebulizer system. Breath Therapeutics is a spin off from PARI, which initially developed the formulation; PARI licensed L-CsA-i to the new company in 2017. Both the FDA and EMA have granted orphan drug designation to L-CsA-i for the treatment of BOS.
Breath Therapeutics Chief Medical Officer Noreen R. Henig commented, “We are pleased with the significant advancements we’ve achieved in the development of L-CsA-i for the treatment of BOS. The robust BOSTON development plan will provide essential information about the safety and efficacy of L-CsA-i for most patients suffering from BOS. With BOSTON‑1, -2, -3, and -4, we focus on two populations with a high incidence and prevalence of BOS — patients with BOS following lung transplant or BOS following alloHSCT. Our BOSTON‑1 and ‑2 pivotal studies are well underway and, with the initiation of BOSTON-3 and -4, we are one step closer in realizing our vision of bringing L-CsA-i to patients with BOS.”
Read the Breath Therapeutics press release.
