Date: 2015-03-03
Type of information: Results
phase: 2a
Announcement: results
Company: Apeptico (Austria)
Product: solnatide - AP301 - synthetic peptide L-cysteine, L-cysteinylglycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-Lthreonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glutamyl-L-alanyl-L-lysyl-L-prolyl-Ltryptophyl-L-tyrosyl-,cyclic (1.fwdarw.17)-disulfide
Action
mechanism: peptide. Solnatide (AP301) is a fully synthetic peptide whose structure is based on the lectin-like domain of human Tumour Necrosis Factor alpha. This peptide activates alveolar liquid clearance (ALC) and prevents both endothelial and epithelial lung tissue from hyper-permeability as a result of microbial and viral lung infections. AP301 also prevents ischaemia reperfusion injury following lung transplantation in the lower respiratory tract.
Disease: primary graft dysfunction following lung transplantation
Therapeutic area: Rare diseases - Transplantation - Lung diseases
Country: Austria
Trial
details: The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation. (NCT02095626 )
Latest
news: * On March 3, 2015, Apeptico announced that the phase IIa clinical study of AP301-peptide delivered topline
results in the treatment of primary graft dysfunction in patients following lung transplantation. 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.
