Cystic fibrosis treatment to be fast-tracked through US review

Novabiotics founder Deborah O'Neil

One of the firms helping to grow Aberdeen’s reputation as a global centre of excellence for ground-breaking life sciences research and development has achieved a key milestone in the US.

NovaBiotics said yesterday its orally administered Lynovex therapy for cystic fibrosis (CF) sufferers had been given fast-track designation (FTD) status by America’s Food and Drink Administration (FDA).

It means the drug, which has been developed for the treatment of CF-associated lung disease, can pass through the US review process quicker.

The therapy is in a global second phase clinical trial.

According to NovaBiotics, based at Craibstone, FTD recognises its potential for treating CF-related conditions for which there are no specific therapeutic interventions.

The European Medicines Agency and FDA have both already designated Lynovex as an orphan drug – the term used to describe a pharmaceutical agent that has been developed specifically to treat a rare medical condition.

Lynovex breaks down the thick, sticky mucus produced by the lining of the airways in CF patients, and kills the bacteria that thrive in this environment and occasionally cause serious chest infections.

The drug has also been found to boost the effectiveness of antibiotics and is intended for use alongside these and other therapies, as well as “modifiers” that can work in certain patients to correct the faulty protein that causes CF.

NovaBiotics chief executive Deborah O’Neil said “Gaining FDA fast-track designation for oral Lynovex marks a very significant milestone in the development of this important drug and is recognition of its novelty and its potential clinical impact in CF.

“Lynovex in oral form is unique as the only therapy specifically designed to tackle exacerbations, despite these events being the main driver of pathology and decline in lung function over time in CF patients.”

NovaBiotics was founded by Ms O’Neil in 2004 and has spent the past 14 years working to rid the world of a range of debilitating conditions.

Other products the company is working on include innovative treatments for conditions including MRSA and fungal nail infection.