In lung transplantation (LuTX), a healthy lung from a deceased donor replaces the damaged lung of a patient to increase quality of life or even survival time of the recipient. Despite refinements in lung preservation and improvements in surgical techniques and perioperative care, primary graft dysfunction (PGD) remains a significant cause of early morbidity and mortality after lung transplantation. In addition to significant morbidity and mortality in the early postoperative period, PGD can also be associated with an increased risk of acute rejection that may lead to graft dysfunction in the long term. Currently, there is no effective pharmacotherapy available for treatment of PGD.
The proof-of-concept phase IIa clinical study was conducted at the Departments of Thoracic Surgery and Intensive Care Medicine of the Medical University of Vienna. The primary objective of this interventional, randomised, placebo-controlled study was to assess the clinical effect of orally inhaled AP301-peptide on treatment of PGD in patients after primary lung transplantation in comparison to placebo.
Results from this study showed that oral inhalation of AP301-peptide led to an early resolution of pulmonary oedema, pronounced improvement of gas exchange and normalisation of respiratory parameters, shortening of duration of mechanical ventilation and intensive care treatment, and earlier discharge of patients from hospital, when compared to placebo. On average, AP301-peptide treated patients were weaned from mechanical ventilation 1.5 days earlier, ICU treatment was terminated 3 days earlier and patients were discharged from the hospital up to 5 days earlier.
Dr. Bernhard Fischer, CEO of Apeptico, stated: “We are very proud to have achieved this significant clinical goal. The results of this clinical study in lung transplantation strongly support previous findings from our previous trial in mechanically ventilated patients with pulmonary permeability oedema and ARDS. Our AP301-peptide is a very effective compound mediating recovery of normal lung function following lung injury and ischemia reperfusion injury. This major success would not have been possible without the enthusiastic support of the clinical study teams of Professor Walter Klepetko and Professor Clemens Aigner (Division Thoracic Surgery), and Professor Roman Ullrich and Professor Klaus Markstaller (Division of General Anaesthesia and Intensive Care Medicine) of the Medical University Vienna.” “Our excellent scientific and clinical data are the basis for partnership with global and specialised pharmaceutical and biotech companies” Dr. Fischer added.