ViiV Healthcare, a subsidiary of GlaxoSmithKline (GSK), announced positive results from its Phase IIb EMBRACE study evaluating the investigational broadly neutralising antibody N6LS (VH3810109 or VH109).
The study demonstrated that when administered every four months alongside long-acting cabotegravir (CAB-LA), N6LS effectively maintained viral suppression in adults with HIV who were already stable on treatment.
The six-month primary analysis of the EMBRACE study showed that 96% of participants receiving VH109 intravenously at 60 mg/kg and 88% of those receiving a 3000 mg subcutaneous dose with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL.
This was comparable to the 96% suppression rate in the standard-of-care group. VH109 was administered every four months in both study arms, combined with monthly CAB-LA. Confirmed virologic failure was observed in two participants from each VH109 group.
The findings contribute to growing research supporting the potential of N6LS as a component of a long-acting HIV treatment regimen. The study results further reinforce its antiviral activity, with data indicating that a regimen incorporating N6LS could provide an alternative to existing treatment approaches.
ViiV Healthcare research and development head Kimberly Smith said: “The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months.
“We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.”
An extension of the EMBRACE study will evaluate a six-month dosing schedule of N6LS in combination with CAB-LA to assess the potential for further reducing treatment frequency.
At the six-month assessment, 4% of the intravenous group and 6% of the subcutaneous group recorded HIV-1 RNA levels above 50 copies/mL, while no participants in the standard-of-care group had viral loads exceeding this threshold.
VH109 was generally well tolerated, though injection site reactions were more frequent among those receiving subcutaneous administration, affecting 14% of participants compared to none in the intravenous group.
Study-related adverse events were reported in 64% of the intravenous cohort and 65% of the subcutaneous group, with 16% of subcutaneous recipients experiencing grade 3-4 adverse events, primarily erythema. No grade 3-4 adverse events were recorded in the intravenous group.
Following the favourable outcomes observed, ViiV Healthcare plans to advance research on a six-month intravenous formulation of VH109 in combination with CAB-LA. This will be assessed further in an upcoming phase of the EMBRACE study.
ViiV Healthcare also presented new data from two implementation studies evaluating Apretude, a long-acting injectable approved for HIV prevention.
Findings indicated no reported cases of HIV acquisition among participants in the US and Brazil, highlighting the effectiveness of cabotegravir long-acting (CAB-LA) for pre-exposure prophylaxis (PrEP) in diverse clinical settings and populations.
Additionally, real-world data were shared on Cabenuva, a long-acting injectable treatment regimen for HIV, comprising cabotegravir and rilpivirine (CAB+RPV LA). Results from two large-scale studies demonstrated sustained effectiveness over three years, supporting its role as a viable long-term treatment option for people living with HIV.
