Potential Nitric Oxide Treatment for Resistant Bacterial Infections Gets Patent, May Start Clinical Testing

A possible inhalable treatment for antibiotic-resistant bacterial infections in people with cystic fibrosis due to Pseudomonas aeruginosa now has a U.S. patent and is being readied for a first clinical trial, Novoclem Therapeutics announced.

The patent (No. 9,850,322) was issued to the University of North Carolina (UNC) at Chapel Hill where the potential therapy, BIOC51, was discovered, and covers a technology known as water-soluble polyglucosamine compositions that release nitric oxide.

Novoclem holds an exclusive license to BIOC51 and will further develop it, including applying to the U.S. Food and Drug Administration (FDA) for the right to test it in people in a controlled study later this year. It also has rights to other respiratory disease treatments developed under the patent.

The bacterium P. aeruginosa causes chronic lung infections in CF patients. Its antibiotic resistance, coupled with the thick mucus commonly found in CF patients’ lungs, makes it difficult to treat P. aeruginosa infections.

BIOC51 was designed to be inhaled as a dry powder or nebulized solution and penetrate mucus to better reach and eliminate P. aeruginosa. It releases nitric oxide in controlled amounts to attack both free-floating bacteria and bacteria growing in biofilms — a slimy protective substance that develops when bacteria gather on surfaces, like the walls of a patient’s lungs.

“Obtaining this patent is an important milestone in our journey towards building out our nitric oxide-releasing product pipeline,” Mark Schoenfisch, the technology’s co-inventor and chief scientific officer at Novoclem, said in a press release.

“Having a water soluble, tunable system for releasing nitric oxide created a new paradigm for treating disease … [and] an ability to deliver nitric oxide to a much broader range of locations within the body,” added Schoenfisch, a chemistry professor at UNC.

Nitric oxide has several properties, including antimicrobial activity.

“Issuance of this patent is particularly satisfying,” said Anne Whitaker, chief executive officer at Novoclem. “This technology is foundational, so … an issued patent puts us in a better position to engage investors and partners — we are confident about this technology helping those living with CF.”

BIOC51 was given qualified infectious disease product (QIDP) status by the FDA in 2017 as a potential treatment for recurrent lung infections caused by bacteria.