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news.Apeptico has commenced a randomized, double-blind, placebo-controlled, dose escalating Phase I clinical trail to evaluate the safety and tolerability of its orally inhaled peptide drug AP301 in patients suffering from oedematous respiratory failure from lung infection, lung injury and lung transplantation.
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AP301 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.
In the trial, up to 48 patients are expected to get a single dose of AP301 or matching placebo converted into an aerosol by nebuliser technology.
Apeptico CEO Bernhard Fischer said they are very pleased to expand the development of their lead molecule AP301 into clinical studies, particularly as they have faced widespread scepticism regarding the usefulness of peptide drugs in inhalation therapy.