New CF treatment gains EU orphan drug status

 Scottish biotechnology company NovaBiotics has received orphan drug designation in Europe for Lynovex (cysteamine), a dual-action mucolytic and antibacterial drug to treat cystic fibrosis (CF).

Lynovex, delivered as an aerosol spray, is the first drug to protect people with CF by simultaneously attacking bacteria and reducing mucous production in airways.

NovaBiotics is now in discussion with a number of companies that may license or co-develop the drug.

Orphan drug status is granted by the European Medicines Agency to drugs used to prevent or treat serious conditions affecting no more than 5 in 10,000 people.

The designation gives the drug marketing exclusivity in the EU for 10 years after its approval, as well as a faster route to clinical use.

CF is a genetic disease that affects over 7,000 people in the UK. It causes chronic over-production of mucus in airways, exposing them to dangerous infections. CF sufferers have an average life expectancy of 37 years.

Lynovex addresses the overproduction of mucous while disrupting biofilms and attacking bacteria. Sprayed directly into the patient’s airway, it can improve the effectiveness of currently used inhaled antibiotics.

Dr Deborah O’Neil, CEO of NovaBiotics, said: “Lynovex already has a well-established history of safety. This first-in-class drug candidate outperforms currently marketed products in its mucolytic action. In addition, its antibiofilm properties and synergy with other antibacterial treatments could go a long way to changing or even extending the lives of those living with cystic fibrosis.

“This novel drug candidate is expected to be tested in patients in 2012.”

Based in Aberdeen, NovaBiotics specialises in developing new antifungal and antibacterial drugs.