Biota Pharma Gets Fast Track Designation From FDA For BTA585

(RTTNews) - Biota Pharmaceuticals, Inc. (BOTA) Tuesday said the U.S. Food and Drug Administration has granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus infections in infants, young children and adults.

Fast Track process will help expedite the development and review of drugs for serious or life-threatening conditions.

Currently there are no direct antiviral products approved to treat the millions of respiratory syncytial virus infections that occur each year in the U.S.

BTA585 is an oral fusion inhibitor in development for the treatment and prevention of respiratory syncytial virus infections, and it has successfully completed a Phase 1 single ascending dose trial and dosing in a multiple ascending dose trial. Phase 2 challenge trial is expected to begin in the second quarter of 2016.