KNOW Bio – Vast Therapeutics Receives Qualified Infectious Disease Product Status for BIOC11
DURHAM, NC – October 8, 2019 – Vast Therapeutics, Inc., a subsidiary of KNOW Bio, LLC, today announced that another of its drug candidates, BIOC11, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food and Drug Administration. Vast is a preclinical-stage pharmaceutical company focused on treating respiratory infections through the power of nitric oxide (NO) in a synthetically derived powder-based form. The QIDP designation, granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, will make BIOC11 eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, BIOC11 is eligible for an additional five-year extension of market exclusivity.