Date: 2011-04-07
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
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: pulmonary edema
Therapeutic area: Respiratory diseases
Country: Austria
Trial
details: * On April 7, 2011, Apeptico has announced the initiation of a Phase I clinical trial with AP301 to assess the safety and tolerability of the orally inhaled peptide drug. AP301 is being developed for the treatment of oedematous respiratory failure in patients suffering from lung infection, lung injury and lung transplantation.The randomized, double-blind, placebo-controlled, dose escalating study is enrolled in Austria. Up to 48 patients will receive a single dose of AP301 or matching placebo converted into an aerosol by state-of-the-art nebuliser technology.
Latest
news: Apeptico also announced that the company seeks partner for further development of AP301 in influenza. Apeptico indicates that treatment of influenza virus-infected mice with AP301 results in a significant reduction of oedema fluid accumulation in the air space and increased alveolar liquid clearance. AP301 acts synergistically with anti-viral neuraminidase inhibitor, such as oseltamivir and zanamivir, in influenza virus-infected mice by reducing virus-mediated lung oedema and by prevention of endothelial/epithelial hyper-permeability. In a porcine model of acute lung injury, inhalation of AP301 peptide results in a sustained improvement of the lung function according to the parameters oxygenation index, extravascular lung water (EVLWI) and pulmonary shunt fraction.
