Biota Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults.
The FDA Fast Track process is designed to expedite the development and review of drugs used in the treatment of serious or life-threatening conditions and which demonstrate potential to address unmet medical needs.
BTA585 is an oral RSV fusion inhibitor in development for the treatment and prevention of RSV infections. BTA585 has successfully completed a Phase 1 single ascending dose trial and has recently completed dosing in a multiple ascending dose trial with results expected to be reported this quarter. A Phase 2 RSV challenge trial is expected to begin in the second quarter of 2016.
