BIOC51, a potential nitric oxide-based treatment of chronic pulmonary infections due to resistant bacteria in patients with cystic fibrosis (CF),was awarded special status to promote and speed its development, Novoclem Therapeutics announced.
BIOC51 was granted what is known as Qualified Infectious Disease Product (QIDP) status by the U.S. Food and Drug Administration (FDA), whose incentives include priority review and fast-track eligibility, the company announced in a press release.
Pseudomonas aeruginosa is a bacteria that causes chronic lung infections in CF patients and resistant to conventional antibiotics. The thick mucus layer commonly in the lungs of CF patients also makes it difficult for antibiotics to reach the bacterial colonies there.
An inhalable treatment, BIOC51 is designed to penetrate that mucus to reach and kill Pseudomonas aeruginosa bacteria. BIOC51’s mode of action involves the controlled release of the chemical nitric oxide in order to eradicate both free-floating bacteria and bacteria growing in biofilms, which develop when bacteria stick together on surfaces and excrete a slimy, glue-like, protective substance.