Healthy Living

Cystic Fibrosis Treatments on the Horizon

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.