- The FDA grants Qualified Infectious Disease Product (QIDP) designation to Spero Therapeutics' (NASDAQ:SPRO) SPR206, a product candidate within Spero’s Potentiator Platform for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
- QIDP status allows accelerated review of the marketing application and provides for an additional five-year period of market exclusivity for the indication, if approved.
- Spero plans to initiate a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of SPR206 in 2019.