Initiation of a Phase IIa Clinical Study for Lynovex in Cystic Fibrosis

27-Jun-2014 - United Kingdom

NovaBiotics Ltd, a Aberdeen-based speciality biotechnology company, announced the initiation of an open label/single arm Phase IIa clinical study to assess the safety, tolerability, pharmacokinetics and initial evidence of efficacy of orally-dosed Lynovex®. The Phase IIa trial will be undertaken in collaboration with the University of Aberdeen and NHS Grampian.

Lynovex® is a candidate therapeutic for cystic fibrosis and has unique multi-functionality. Lynovex® has the potential to break down the mucus produced in the airways of CF patients and at the same time, has been shown to kill the bacteria responsible for the recurrent respiratory infections in cystic fibrosis. Furthermore, Lynovex® disrupts and prevents the biofilms which these bacteria typically form in the cystic fibrosis airway. By functioning in this way, Lynovex® could improve lung function and halt or prevent long term damage or degeneration of respiratory tissues in CF patients. Lynovex® has been designated as an Orphan Drug by the EMA.

The trial follows the generation of very promising results from a study in which the antibacterial and mucolytic impact of Lynovex® was determined against sputum samples from cystic fibrosis patients. The Phase IIa study will determine levels of Lynovex® in the blood and sputum of cystic fibrosis patients after it has been administered in tablet form and will monitor levels of bacteria in sputum, lung function and weight as well as general health and quality of life parameters. Results from the trial are expected to be announced H2 2014 and are part of the Company’s wider plan to develop orally administered Lynovex® as an intervention in acute exacerbations of cystic fibrosis.

https://www.bionity.com/en/news/148866/initiation-of-a-phase-iia-clinical-study-for-lynovex-in-cystic-fibrosis.html