Neem Biotech and the Mukoviszidose Institut in Germany are delighted to announce that Neem’s lead candidate NX-AS-401 has recently received Orphan Drug Designation from the United States FDA for treatment of chronic Pseudomonas aeruginosa infections in patients with cystic fibrosis.

This means that the FDA has recognised the promise that NX-AS-401 holds as an alternative to conventional antibiotics. The Pseudomonas aeruginosa bacteria that cause these chronic lung infections in people who suffer from cystic fibrosis are often resistant to the antibiotics that are prescribed. When used in combination, NX-AS-401 boosts the effectiveness of these antibiotics and aims to reduce the number of Pseudomonas aeruginosa caused exacerbations of lung infection that occur in these patients.  

In practice this recognition is a fantastic boost to the ongoing development of our flagship candidate drug substance. Watch this space for the outcome of our application for Orphan Drug Designation from the European Medicine Agency for NX-AS-401.