N6LS was administered in both arms every four months, combined with monthly cabotegravir long-acting injections. Credit: Shutterstock / cawee.
ViiV Healthcare is looking to investigate twice-yearly dosing of its human immunodeficiency virus (HIV) therapy, which has been able to suppress viral load in patients dosed every four months in a Phase IIb trial.
Results from the company’s Embrace trial (NCT05996471) found that 96% of patients dosed with 60mg/kg N6LS (VH109) intravenously (IV), were able to maintain HIV-1 RNA levels below 50 copies per millimetre in blood, compared to 96% in the standard-of-care (SoC) group, who received antiretroviral therapies (ART).
At the same time, 88% of another group receiving 3,000mg of N6LS subcutaneously alongside recombinant human hyaluronidase (rHuPH20), were also able to achieve the same effect, maintaining viral load below detectable levels.
N6LS was administered in both arms every four months, combined with monthly cabotegravir long-acting injections, in this case using the company’s other proprietary HIV regimen, Cabenuva (cabotegravir and rilpivirine). Virologic failure was observed in two patients from each group.
Results from the Embrace trial were presented as part of the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, with the company adding that it plans to advance N6LS to six-monthly IV dosing in combination with Cabenuva as part of the Embrace part two study.
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.”
The London-based company is majority-owned by UK pharmaceutical giant GSK with companies such as Pfizer and Shionogi holding minority shares in the company. The Phase IIb multi-centre, randomised, open-label study recruited 134 patients at 45 locations across the US.
The company describes N6LS as a broadly neutralising antibody (bNAbs), a type of antibody that can recognise and block the entry of a broad range of different strains of HIV into healthy cells.
The trial secondary endpoint examining the number of AEs found that 64% of the IV group and 65% of the subcutaneous group experienced some form of treatment-related AE. 16% of patients in the subcutaneous group experienced grade 3 and 4 erythema. Infusion site reactions were reported in no IV patients, but 14% of patients in the subcutaneous group.
Research by GlobalData’s pharmaceutical research centre details that should N6LS make it to market, it is estimated to bring in $41m for ViiV Healthcare, with that figure expected to rise to $247m by the end of 2031.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the world of HIV therapies, Gilead is set to launch a Phase III trial of its once-yearly lenacapavir pre-exposure prophylaxis (PrEP) for the disease. Meanwhile, massive cutbacks in USAID funding are set to have ramifications on international research in diseases such as HIV.
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