NovaBiotics announced that the FDA has granted Orphan Drug designation to Lynovex (NM001) for the treatment of cystic fibrosis (CF).

Lynovex has a dual antibacterial-mucoactive mode of action that aggressively tackles both of the major clinical features responsible for progressive lung disease in cystic fibrosis. Lynovex is active against drug resistant bacteria as well as bacteria that are in biofilm form. It also reverses antibiotic resistance in bacteria to conventional antibiotics when used alongside these drugs.

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Lynovex is being developed as an oral tablet for acute exacerbations and as an inhaled dry powder for chronic use and maintenance. Lynovex is intended for use alongside existing cystic fibrosis treatments and potentiates their antimicrobial effects. A Phase 2a clinical trial for the oral form of Lynovex is already underway. Clinical development of the inhaled form is also anticipated to get underway in 2015.

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