Novoclem’s Candidate Therapy Shows Promise Against 9 Pathogens Associated with Cystic Fibrosis Infection

Novoclem Therapeutics’ lead drug candidate, a nitric oxide-releasing biopolymer, can eliminate nine of the most prevalent microorganisms responsible for severe lung infections in cystic fibrosis (CF) patients, the Morrisville, N.C., company reported.

“Our mission is to arm patients with therapies that treat resistant bacteria and enable them to breathe better and live more fully,” Novoclem CEO and President Anne Whitaker said in a press release. “We are committed to bring to market breakthrough antimicrobial therapies that will address the growing need of patients with severe lung diseases like cystic fibrosis. Based on initial studies, we believe our new drug candidate will do just that.”

Nitric oxide, or NO, is an important player in the normal immune system response against microorganisms that can cause disease. It also regulates the inflammatory process. Novoclem’s NO-releasing biopolymer makes it possible to regulate both the immune system and inflammation with just one treatment, said the company, formerly known as KNOW Bio Respiratory.

Independent studies by the Southern Research Institute showed that the drug candidate can effectively tackle several disease-associated microorganisms, many of which the U.S. Food and Drug Administration (FDA) considers a public health threat. These include methicillin-resistant Staphylococcus aureus, methicillin-sensitive Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia, Mycobacterium Avium-Intracellulare Complex (MAC), Mycobacterium abscessus, Achromobacter xylosoxidans and Stenotrophomonas maltophilia.

This treatment strategy can help eliminate infections caused by multi-drug resistant microorganisms, which can be found in many CF patients, while attacking other species which, despite their low incidence, increasingly threaten such patients.

“The findings suggest that Novoclem’s product has great clinical utility across a range of difficult-to-treat infections,” said Mark Schoenfisch, a chemistry professor at the University of North Carolina at Chapel Hill and Novoclem’s chief science officer. “That’s why we believe our technology will be able to break down the bacterial drug resistance barrier and soon we’ll be able to effectively treat many types of lung infections.”

Novoclem will soon apply to the FDA for Investigational New Drug status and plans to begin its first clinical trial in early 2018.