NovaBiotics has successfully employed the links with the research group of Prof Graham Deverux at the University of Aberdeen through a Kick Start Award project to explore the performance of Lynovex, a new drug to fight against cystic fibrosis (CF), the commonest lethal inherited disease in Caucasian populations. The company has benefited significantly from Prof Devereux’s academic and clinical research expertise since it ensured relevant clinical input into development of this drug candidate, as well as provided access to the Scottish CF community through Prof Devereux’s links with the Scottish CF Group. In turn, the opportunity to contribute to the development of an easily administered effective oral antimicrobial agent that improves the life expectancy and health status of CF patients is intellectually and clinically attractive to a CF clinician.
The project focused on obtaining more physiologically relevant information about the mucolytic-antimicrobial function of Lynovex in the altered physiology/complex environment of the patient-derived sputum; also, it enquired patients about preferred formulation and frequency of administration for Lynovex has provided guidance as to how to further develop the drug.
The impact Lynovex was confirmed by significant reductions in total microbial load from a single exposure to the drug even in as short a timeframe as 4 hours, alone or in combination with Tobramycin. This outperforms the ‘gold standard’ mucolytic and antibiotic treatment options (NAC and Tobramycin) in CF in its antimicrobial capacity and supports previous findings of synergy between Lynovex and conventional antibiotics, pointing to the application of this new drug as an adjunct therapy alongside existing CF antibiotic regimens.
The data generated from this project have been included in a clinical trial application to the European Medicines Agency (EMA) under the orphan drug protocol assistance scheme, ahead of an application for a first time in man, clinical study in which the safety, tolerability and initial evidence of efficacy of orally administered Lynovex will be assessed. This project has generated interest and the potential for support from Health Science Scotland and the CF Trust who will co-fund fund the planned trial.
Dr Miguel Rey, Research & Innovation
Email: Miguel Rey
Tel: 01224 274157