The multinational study is investigating the safety and efficacy of Pari’s L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to Pari’s drug-device combination were encouraging.
Pari’s Phase 2b trial is a multi-center, randomised, double-blind, placebo controlled, parallel group, dose-finding study to investigate the safety and efficacy of L-CsA in doses of 10mg/day and 20mg/day to prevent bronchiolitis obliterans in recipients of lung transplants.
Manfred Keller, chief scientific officer and executive vice president of Pari Pharma, said: “We are very pleased to move forward with this investigational treatment aimed at preventing bronchiolitis obliterans, which is an incurable small airway disease in lung transplant recipients. This study has been designed with advice from the European Medicines Agency under L-CsA’s orphan drug designation status.”
Martin Knoch, president of Pari Pharma, said: “We are seeing early success from our L-CsA program. This underscores PARI Pharma’s unique position to combine formulation expertise with our advanced aerosol delivery technology to develop best in class therapies for unmet medical needs.”