Latest news with #N6LS
Yahoo
17-03-2025
- Business
- Yahoo
ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success
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. "ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
13-03-2025
- Business
- Yahoo
ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success
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 ml 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 3000mg 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. Kimberly Smith, head of research & development at ViiV Healthcare, 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 multicentre, 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 is set to have ramifications on international research in diseases such as HIV. "ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
