Therapy Areas: Hereditary Disorders
Vast Therapeutics' BIOC11 named 'Qualified Infectious Disease Product' by US FDA
9 October 2019 -

Vast Therapeutics Inc, a subsidiary of KNOW Bio LLC, announced yesterday that another of its drug candidates, BIOC11, has been named as a 'Qualified Infectious Disease Product' (QIDP) by the United States Food and Drug Administration (US FDA).

The QIDP designation has been granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis and will make BIOC11 eligible to benefit from certain incentives for the development of new antibiotics offered under the Generating Antibiotic Incentives Now Act. These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the US FDA, BIOC11 is eligible for an additional five-year extension of market exclusivity.

Mark Schoenfisch, president and CSO of Vast Therapeutics, said, 'We are very pleased that the FDA has granted QIDP designation to BIOC11. BIOC11 reflects an advanced platform for the delivery of nitric oxide and demonstrates that our nitric oxide-releasing pipeline is deep with additional candidates. Chronic, persistent lung infections continue to increase in frequency and are a major factor impacting the quality of life and untimely mortality of patients across a broad spectrum of diseases. The QIDP designation will accelerate the advancement of BIOC11 regulatory approval as a potential treatment for these patients.'