Biota Pharmaceuticals has started a Phase 2a study of BTA585, which is an oral fusion inhibitor being developed for treatment and prevention of respiratory syncytial virus (RSV) infections.
In February, BTA585 received Fast Track designation from the US Food and Drug Administration (FDA) for RSV infections in infants, young children and adults.
FDA Fast Track process is designed to accelerate development and review of drugs used in the treatment of serious or life-threatening conditions, as well as demonstrating potential to address medical needs.
During the double-blind, placebo-controlled, Phase 2a trial, the safety, pharmacokinetics, and antiviral activity of orally dosed BTA585 in healthy volunteers challenged intranasally with RSV will be evaluated.
Following a positive test for RSV or five days after the study, around 60 healthy adults will be randomised to receive either BTA585 or placebo, dosed twice daily for seven days and monitored for 28 days.
The study’s primary endpoint includes the area under the curve for the viral load in nasal wash among subjects who test positive for RSV prior to dosing. Secondary endpoints include measures of RSV clinical symptoms and other viral load endpoints including peak viral load and time to cessation of virus detection.
The study also includes assessment of PK levels in both plasma and nasal wash.
Biota Pharmaceuticals president and chief executive officer Joseph Patti said: "We are pleased to initiate this Phase 2a challenge study just seven months after initiating our first-in-man Phase 1 study with BTA585.
"The rapid progress of the programme has been encouraging and reinforces our commitment to developing a safe and efficacious treatment for the millions of children that suffer annually from serious RSV infections.
"We expect data readout from this challenge study later this year, which will help inform our plans for a Phase 2b natural exposure trial in this important indication."
