Bitop AG, a biotech company specializing in the development of Ectoin-containing medical devices, announced the inclusion of the first patient into a clinical trial on the Ectoin inhalation solution in patients with inflammation and airway obstruction.
The present clinical study is a single-centre efficacy and feasibility study involving patients with inflammation and airway obstruction in Germany. After the successful feasibility a long term study extension will investigate the effect of Ectoin Inhalation Solution of lung function decline, lung ageing and inflammation. bitop makes use of Pari Pharma´s eFlow nebulisation technology to obtain optimal delivery of the Ectoin Inhalation Solution into the lungs.
“Environmental pollution of the lungs poses a growing problem for the inhabitants of industrialised countries, leading to diseases like COPD with a high economic burden. The local application of cell-protection molecules like Ectoin opens up new options for treatment in this field, " states Prof Ursula Kraemer at the Leibniz-Institut für Umweltmedizinische Forschung.
Recent clinical studies with Ectoin-containing medical devices show excellent results in efficacy and safety in the treatment of allergic rhinitis and conjunctivitis or atopic dermatitis.
Ectoin Inhalation Solution has already shown marked therapeutic efficacy in the treatment of mild asthma in humans and in animal models of nanoparticle-induced inflammatory reaction in the lungs, allergen induced asthma.
The extremolyte Ectoin (2-Methyl-1,4,5,6-tetrahydropyrimidine-4-carboxylic acid) is a cyclic amino acid that is produced mainly by halophilic bacteria to protect the cells from the extreme osmotic stress associated with saline conditions. Ectoin protects biological macromolecules and structures from adverse environmental conditions, minimizes the denaturation of biopolymers occurring under water stress conditions, and stabilizes proteins by maintaining the protein hydration structure.
The mode of action of Ectoin Inhalation Solution is associated with the water retaining capability of Ectoin and the formation of a protective hydro complex on the lung epithelium which shields the cells against stress. Furthermore, Ectoin is able to protect human tissue cells by interfering with signaling pathways that are initiated at the level of the cell membrane. Ectoin is water-soluble, chemically stable, non-toxic and highly compatible with cell metabolism. bitop AG develops Ectoin for the
"Ectoin-containing medical devices have already shown very positive effects in different diseases. We hope that we can show in this study that Ectoin Inhalation Solution can be used to protect individuals against unavoidable environmental nanoparticle-induced inflammatory reaction in the lung” says Dr Andreas Bilstein, Head of Medical Device Development at bitop AG.
bitop AG
