ViiV Healthcare announces data from EMBRACE Phase IIb study

ViiV Healthcare, majority owned by GSK (GSK), with Pfizer (PFE) (PE) and Shionogi as shareholders, announced findings from the company’s EMBRACE phase IIb study. The study found that N6LS, given every four months in combination with monthly cabotegravir long-acting, kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously and 88% receiving VH109 3000mg subcutaneously with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group. Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six. VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events. No participants in the IV group experienced a grade 3-4 adverse event. Based on the results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial.