Results of phase Ib clinical trial for L-CsA, inhaled liposomal cyclosporine A, were published in Journal of Aerosol Medicine and Pulmonary Drug Delivery. L-CsA is delivered via an Investigational eFlow Nebulizer System for the prevention and treatment of bronchiolitis obliterans.
PARI pharma received FDA’ Orphan Drug Designation for L-CsA last month.
Phase Ib clinical trial for L-CsA studied 12 lung transplant recipients, where five patients had double lung transplants and seven patients had single lung transplants. Patients were given a single dose application of 10mg or 20mg of liposomal L-CsA, which was well tolerated. Deposition data showed a peripheral lung deposition of 2mg for a nominal, 10mg dose that was nebulized in less than ten minutes.
Dr. Manfred Keller, Executive Vice President and Chief Scientific Officer of PARI Pharma, said: The long-term survival rate for lung transplant patients could be greatly improved through an effective inhaled liposomal cyclosporine therapy. Using our proprietary liposomal technology we created an inhaled formulation that is free from irritating solvents and optimized for administration via an Investigational eFlow Nebulizer System without destroying the liposome.
We had a very encouraging pre-IND meeting with the FDA, and their recent Orphan Drug Designation for L-CsA, which follows a similar designation in Europe, encourages us to move forward to solve this unmet medical need.