Posted by Michael Wonder on 27 Jul 2017
Sequoia Sciences receives FDA fast track designation for vaccine for urinary tract infections caused by multidrug-resistant bacteria
26 July 2017 - Non-antibiotic treatment approach may reduce the development of antibiotic resistance and promote antibiotic stewardship.
Sequoia Sciences announced it has received fast track designation from the U.S. FDA for its novel, investigational vaccine designed to treat recurrent urinary tract infections (UTI) caused by multidrug-resistant bacteria.
Sequoia's vaccine is designed to create an immune response preventing bacteria from colonizing the urinary tract, and it recently completed its first clinical trial in women. Of the 67 women enrolled in this first study, 30 had a two-year documented history of recurrent UTI. The vaccine was well-tolerated and generated a strong immune response [1]. Based on the results of this first study, initiation of additional studies is ongoing including evaluating Sequoia's vaccine in patients requiring last-line of defense antibiotics. In granting fast track status, the FDA acknowledges that recurrent UTI caused by multidrug-resistant bacteria is a serious condition for which there is an unmet medical need.
