Positive Phase III results from the BRIGHTE study of fostemsavir

ViiV Healthcare, the global specialist HIV company majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK), with Pfizer and Shionogi as shareholders, today announced results from the Phase III BRIGHTE study of fostemsavir in heavily treatment-experienced (HTE) patients with HIV-1 infection.

Following one week of treatment, HTE patients receiving fostemsavir added to a failing regimen experienced a greater reduction in HIV-1 viral load compared to patients receiving placebo, demonstrating statistical superiority of fostemsavir over placebo (0.79 log10 c/mL versus 0.17 log10 c/mL; p<0.0001).

GSK and ViiV, which was established in 2009, acquired rights to fostemsavir in December 2015, as part of a $1.4 billion deal with Bristol-Myers Squibb (NYSE: BMY). While under the ownership of the US pharma major, fostemsavir received Breakthrough Therapy designation from the US Food and Drug Administration and that time was expected to be filed for regulatory approval in 2018.