NovaBiotics Receives Orphan Drug Status from FDA for Lynovex for the Treatment of Cystic Fibrosis

NovaBiotics has announced that FDA has granted orphan drug designation for Lynovex (NM001), the company’s first-in-class therapeutic candidate for the treatment of Cystic Fibrosis (CF).

It is believed that Lynovex has unique multi-functionality; combined properties of breaking down the excessive mucus produced in the airways of CF patients, killing the bacteria responsible for the recurrent respiratory infections in CF and disrupting/preventing the biofilms which these bacteria typically form in the CF 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 is being developed by NovaBiotics for CF as an oral (tablet) form for acute exacerbations and in inhaled (dry powder) form for chronic use and maintenance. Lynovex is intended for application alongside existing CF treatments and potentiates their antimicrobial effects.  A Phase IIa clinical trial for the oral form of Lynovex is already underway. Phase IIb studies of the oral form of Lynovex in the UK and Europe are expected to commence in 2015.  Clinical development of the inhaled form is also anticipated to get underway in H2 of 2015. 

Dr Deborah O’Neil, CEO of NovaBiotics, said: “The orphan drug designation for Lynovex in the US is a major regulatory milestone for NovaBiotics and highlights the unmet need for effective and safe treatments for CF patients. Dosing of the first patients in the Aberdeen Phase IIa clinical trial is also a significant clinical milestone in Lynovex’s clinical development.”

She added: “If the encouraging data we have achieved so far continues to translate in clinical use, we believe Lynovex will offer a breakthrough in the treatment of CF. This is a candidate therapy with the potential to significantly improve the health and quality of life for those affected by CF. Importantly, and unlike other treatments that are specific to particular CF mutations, Lynovex is intended for use by the entire CF patient population, not just sub-groups.”