The FDA sees promise in this new treatment
“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.
BIOC51 was given qualified infectious disease product (QIDP) status by the United States Federal Drug Administration (FDA) in 2017 as a potential treatment for recurrent lung infections caused by bacteria. A QIDP designation makes BIOC51 eligible to benefit from certain incentives for antibiotic development, under the Generating Antibiotic Incentives Now Act (GAIN Act). In addition to a priority review if it does well in clinical studies and fast-track eligibility, BIOC51 — if approved by the FDA for use — will also be eligible for an additional five-year extension of market exclusivity.