Latest news with #VH109
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
Associated Press
12-03-2025
- Health
- Associated Press
ViiV Healthcare's investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company's EMBRACE phase IIb study. 1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: 'As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. 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.' Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) 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 (erythema). No participants in the IV group experienced a grade 3-4 adverse event. Based on the favourable 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. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in GSK's Annual Report on Form 20-F for 2024. Registered in England & Wales: GSK plc GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage SG1 2NY References ___________________________________ 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA CONTACT: ViiV Healthcare enquiries: Media: Rachel Jaikaran +44 (0) 78 2352 3755 (London)Ken Inchausti +1 732 690 6938 (Philadelphia)GSK enquiries: Media: Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Alison Hunt +1 540 742 3391 (Washington DC)Investor Relations: Annabel Brownrigg-Gleeson +44 (0) 7717 618834 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Camilla Campbell +44 (0) 7803 050238 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) INDUSTRY KEYWORD: AIDS HEALTH FDA GENETICS CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: ViiV Healthcare Copyright Business Wire 2025. PUB: 03/12/2025 11:30 AM/DISC: 03/12/2025 11:32 AM
